Transperineal prostate biopsy device, systems, and methods of use

ABSTRACT

A transperineal biopsy guide including a guide member and a displacement member supported by the guide member. The guide member may be configured to operably couple with the transrectal probe and may include a distal end, a proximal end opposite the distal end, and a length extending along a longitudinal axis between the distal and proximal ends. The displacement member may be configured to support the access needle and displace the access needle along at least a portion of the length of the guide member between the distal and proximal ends. The access needle may extend into the subcutaneous tissue when the access needle is displaced to the distal end.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.14/874,104 filed Oct. 2, 2015, which application is acontinuation-in-part (“CIP”) application of and claims priority to U.S.patent application Ser. No. 14/677,286 (“the '286 application”), nowU.S. Pat. No. 10,064,681, which was filed Apr. 2, 2015, entitled“METHOD, SYSTEM, AND DEVICE FOR PLANNING AND PERFORMING GUIDED ANDFREE-HANDED TRANSPERINEAL PROSTATE BIOPSIES.” The '286 applicationclaims priority under 35 U.S.C. § 119 to U.S. Provisional PatentApplication No. 61/974,826, which was filed Apr. 3, 2014.

All of the above-referenced applications are hereby incorporated byreference in their entireties.

TECHNICAL FIELD

Aspects of the present disclosure relates to biopsy procedures andsystems. In particular, the disclosure relates to methods, systems, andapparatus useful for planning and performing guided and free-handedtransperineal prostate biopsies.

BACKGROUND

A biopsy is a medical procedure that involves sampling and removingtissues or cells from a living body for further examination andanalysis. A prostate biopsy may be performed by a care provider fordiagnosis and treatment of a patient's prostate. For example, the vastmajority of patients with an abnormal prostate specific antigen (PSA) orsuspicious results from a digital rectal examination (DRE) undergobiopsy. Typical biopsy procedures include transrectal ultrasound-guided(TRUS) biopsies and transperineal ultrasound-guided (TPUS) biopsies.

TRUS involves obtaining tissue or cell specimens by passing a biopsyneedle or other biopsy instruments through the rectal wall and into theprostate at various locations using a sagittal imaging plane. The biopsyneedle or other biopsy instruments may be guided by ultrasound in asagittal plane. There are disadvantages associated with TRUS. Inparticular, the patient may be required to take antibiotics prior to theprocedure to reduce the risk of infections. Also, TRUS requires thepatient to perform bowel preparation, which is a procedure usuallyundertaken before the biopsy, for cleansing the intestines of fecalmatter and secretions. Further, the passage of the biopsy needle throughthe rectal wall may introduce bacteria from the rectum into theprostate, such as coliform bacteria that may lead to an infection orother complications. Additionally, many clinically significant prostatecancers are found in locations of the prostate that are often toodifficult to access when using the transrectal approach.

TPUS includes obtaining tissue or cells specimens by passing one or morebiopsy needles through the perineum and into the prostate. TRUS has beenfavored over TPUS. Unlike TRUS, TPUS does not require a patient to takeantibiotics prior to the procedure or to undergo the bowel preparationfor lowering the risk of bacterial issues. Further, TPUS uses a moreeffective route to access the prostate and is capable of accessingtarget locations that may be difficult to access utilizing thetransrectal approach in comparison with TRUS. In addition, the needledoes not pass through the rectal wall which eliminates the riskassociated with TRUS of coliform bacteria entering the prostate or thebloodstream.

Systems configured for TPUS include a biopsy grid that may be fixed to,for example, a floor, platform, or table on which the patient receivingthe biopsy lies. The biopsy grid may provide multiple apertures throughwhich a biopsy needle or other biopsy instruments may be inserted. Anultrasound probe is fixed directly to the apparatus and is used toaxially guide the biopsy needle or other instruments, for example otherbiopsy instruments. Thus, TPUS systems require imaging in an axial planeof the ultrasound or a transverse transducer for positioning the biopsyneedle.

It is with these observations in mind, among others, that variousaspects of the present disclosure were conceived and developed.

SUMMARY

Aspects of the present disclosure involve a biopsy guide configured tocouple with a transrectal probe and for use in guiding an access needlein a transperineal prostate biopsy procedure. The access needle may beconfigured to perforate and be positioned within subcutaneous tissue ofa perineum at an access site of a target area of a patient. The biopsyguide may include a guide member and a displacement member supported bythe guide member. The guide member may be configured to operably couplewith the transrectal probe and including a distal end, a proximal endopposite the distal end, and a length extending along a longitudinalaxis between the distal and proximal ends. The displacement member maybe configured to support the access needle and displace the accessneedle along at least a portion of the length of the guide memberbetween the distal and proximal ends. The access needle may beconfigured to extend into the subcutaneous tissue when the access needleis displaced to the distal end.

In certain embodiments, the biopsy guide may further include the accessneedle.

In certain embodiments, the biopsy guide may further include thetransrectal probe.

In certain embodiments, the displacement member may be configured todisplace along the at least a portion of the length of the guide memberbetween the distal and proximal ends. In certain embodiments, the guidemember may include a guide rail extending at least a portion of thelength between the distal and proximal ends, and the displacement membermay include a coupling mechanism to releasably couple with the guidemember. In certain embodiments, the displacement member may beconfigured to displace relative to the guide member via interaction ofthe coupling mechanism and the guide rail.

In certain embodiments, the displacement member may be configured toslidingly displace relative to the guide member via interaction of thecoupling mechanism and the guide rail.

In certain embodiments, the guide rail may include a first guide railand a second guide rail opposed to the first guide rail, thedisplacement member releasably coupled between the first and the secondguide rails.

In certain embodiments, the coupling mechanism may include: first upperand lower members which may be configured to sandwich the first guiderail; and second upper and lower members which may be configured tosandwich the second guide rail.

In certain embodiments, the coupling mechanism may include upper andlower members which may be configured to sandwich the guide rail.

In certain embodiments, the displacement member may include a pluralityof needle receiving ports for positioning the access needle in aplurality of orientations relative to the transrectal probe. In certainembodiments, each of the plurality of needle receiving ports may beconfigured to align the access needle parallel with a longitudinal axisof the transrectal probe. In certain embodiments, the plurality ofneedle receiving ports may include five needle receiving ports.

In certain embodiments, the biopsy guide may include a lower mountreleasably coupled to the guide member and including a probe couplingmechanism for releasably coupling with the transrectal probe.

In certain embodiments, the probe coupling mechanism extends at leastpartially around the transrectal probe, wherein the guide rail extendsdistally beyond the probe coupling mechanism.

In certain embodiments, the probe coupling mechanism extends at leastpartially around the transrectal probe, wherein the displacement membermay be configured to distally displace beyond the probe couplingmechanism.

In certain embodiments, the guide member may include a slot extending afirst length between the distal and proximal ends, the displacementmember including a rail member may be configured to be received withinthe slot such that the displacement member is displaceable along the atleast a portion of the length of the guide member between the distal andproximal ends. In certain embodiments, a longitudinal axis of the slotis generally parallel with a longitudinal axis of the transrectal probewhen the guide member is secured to the transrectal probe. In certainembodiments, interaction between the slot and the rail member constrainslateral movement of the displacement member relative to the guidemember. In certain embodiments, interaction between the slot and therail member constrains the vertical tilting of the displacement memberrelative to the guide member. In certain embodiments, the displacementmember may include a plurality of needle receiving ports orientedvertically or in a single plane relative to each other. In certainembodiments, the guide member may include a pair of guide rails, thedisplacement member may be configured to displace between the pair ofguide rails.

In certain embodiments, the access needle may extend beyond the distalend of the guide member when the access needle is displaced to thedistal end. In certain embodiments, the access needle may be configuredto be locked into position at the distal end.

Aspects of the present disclosure may also involve a biopsy guide whichmay be configured to couple with a transrectal probe and for use inguiding an access needle in a transperineal prostate biopsy procedure.The access needle may be configured to perforate and be positionedwithin subcutaneous tissue of a perineum at an access site of a targetarea of a patient. The biopsy guide may include a guide member and adisplacement member. The guide member may be configured to operablycouple with the transrectal probe and may include a distal end, aproximal end opposite the distal end, and a length between the distaland proximal ends. The displacement member may be supported by the guidemember and may be configured to support and displace the access needlealong at least a portion of the length of the guide member between thedistal and proximal ends while maintaining a fixed trajectory of theaccess needle.

In certain embodiments, may include the transrectal probe.

In certain embodiments, may include the access needle.

In certain embodiments, the displacement member may slidingly couplewith the guide member via a coupling mechanism such that thedisplacement member is displaceable relative to the guide member. Incertain embodiments, the guide member may include a first rail member,and the coupling mechanism may include upper and lower members thatsandwich the first rail member. In certain embodiments, the guide membermay further include a second rail member opposite the first rail member,the upper and lower members sandwiching the second rail member. Incertain embodiments, the fixed trajectory is generally parallel to alongitudinal axis of the transrectal probe. In certain embodiments, theguide member may include a pair of guide rails extending the length, andthe displacement member may be positioned between the pair of guiderails and slidingly couple with the pair of guide rails via a couplingmechanism. In certain embodiments, the coupling mechanism may includeupper and lower members that sandwich each of the pair of guide rails.

In certain embodiments, the guide member may include a sheath in whichthe probe resides when the guide member is operably coupled with thetransrectal probe.

In certain embodiments, the biopsy guide further includes a mechanicalarrangement between the guide member and the displacement member that atleast facilitates the displacement of the access needle along the atleast a portion of the length of the guide member, wherein themechanical arrangement may include at least one of a slidingarrangement, a lead screw, or a parallel bar linkage.

In certain embodiments, the guide member operably couples with thetransrectal probe via at least one of a sheath arrangement, a ratchetarrangement, a biased collar arrangement, a flexible strap arrangement,a clamping arrangement, or a clamshell collar arrangement.

Aspects of the present disclosure also involve a biopsy guide which maybe configured to couple with a transrectal probe and for use in guidingan access needle in a transperineal prostate biopsy procedure. Theaccess needle may be configured to perforate and be positioned withinsubcutaneous tissue of a perineum at an access site of a target area ofa patient. The transrectal probe may include a distal end, a proximalend opposite the distal end, and a longitudinal axis between the distaland proximal ends. The biopsy guide may include a displacement memberwhich may be configured to be operably coupled with the transrectalprobe and to support and displace the access needle along at least aportion of the transrectal probe. The displacement of the access needlemay be along a trajectory that is parallel to the longitudinal axis ofthe transrectal probe.

In certain embodiments, the biopsy guide may further include a guidemember operably coupled to the displacement member and by which thedisplacement member is operably coupled with the transrectal probe.

In certain embodiments, at least a portion of the displacement memberdisplaces relative to the guide member when the access needle isdisplaced along the trajectory that is parallel to the longitudinal axisof the transrectal probe.

In certain embodiments, the biopsy guide may further include amechanical arrangement between the guide member and the displacementmember that at least facilitates the displacement of the access needlealong the trajectory that is parallel to the longitudinal axis of thetransrectal probe, wherein the mechanical arrangement may include atleast one of a sliding arrangement, a lead screw, or a parallel barlinkage.

In certain embodiments, the guide member may operably couple with thetransrectal probe via at least one of a sheath arrangement, a ratchetarrangement, a biased collar arrangement, a flexible strap arrangement,a clamping arrangement, or a clamshell collar arrangement.

In certain embodiments, the biopsy guide may further include amechanical interface by which the displacement member is operablycoupled with the transrectal probe and by which the displacement memberdisplaces the access needle along the trajectory that is parallel to thelongitudinal axis of the transrectal probe. In certain embodiments, themechanical interface may include at least one of a sliding arrangementdirectly between the transrectal probe and the displacement member or arolling arrangement directly between the transrectal probe and thedisplacement member.

In certain embodiments, the biopsy guide may further include thetransrectal probe and wherein the transrectal probe may include a firstportion of the sliding arrangement and the displacement member mayinclude a second portion of the sliding arrangement directly engaged insliding contact with the first portion. In certain embodiments, at leastone of the first portion or second portion comprises a slot, a rail, ora bar.

In certain embodiments, the biopsy guide may further include thetransrectal probe and wherein the sliding arrangement may include atleast a portion of the displacement member being in direct slidingcontact with an exterior surface of the transrectal probe.

In certain embodiments, the biopsy guide may further include thetransrectal probe and wherein the rolling arrangement may include aroller bearing arrangement supported on the displacement member being indirect rolling contact with an exterior surface of the transrectalprobe.

Related art systems and prostate biopsy TPUS methods do not allowfree-hand movement of the ultrasound probe, and heavily rely on theaxial ultrasound plane to confirm positioning of the biopsy needle orother instruments. Moreover, such systems and methods include extractingprostate tissue specimens by delivering separate punctures into thetransperineal tissue. Also, a care provider executing TPUS procedureusing related art systems may experience substantial difficulty infreely handling and positioning a biopsy needle at a desired targetlocation of the prostate relying on the sagittal plane in using the TRUSmethods.

An apparatus in accordance with an embodiment may include an upper mountand a lower mount. The lower mount may be configured to connect with theupper mount to secure a transrectal probe therebetween. The upper mountmay be configured to support an access needle, the access needleconfigured for perforation of subcutaneous tissue of a perineum at anaccess site of a target area of a patient. The upper mount may beconfigured to guide the access needle whereby movement of the accessneedle is fixed relative to movement of the transrectal probe.

A system in accordance with an embodiment may include a biopsy guide anda transrectal transducer fixed to the biopsy guide. The biopsy guide maybe configured to guide an access needle to perforate an access site insubcutaneous tissue of a perineum, whereby movement of the access needleis fixed relative to a movement of the transrectal transducer.

A method of performing a prostate biopsy in accordance with anembodiment may include imaging a prostate in an axial plane and asagittal plane with a transducer providing a real-time image, locating atarget area of the prostate, and positioning an access needle and anaccess site in subcutaneous tissue of a perineum wherein the access siteis at a midpoint between a lateral edge of the prostate and a urethraalong a first axis and a midpoint between an anterior capsule and aposterior capsule along a second axis. The method may include guiding abiopsy instrument along a sagittal plane to the target using thereal-time image, and obtaining one or more specimens of the prostatethrough the access needle with a biopsy instrument.

Accordingly, there is a demand for transperineal biopsy methods,systems, and apparatus that enables a biopsy that is less burdensome forthe patient and for the practitioner performing the biopsy, increasedguidance of needle or other biopsy instruments, and with a higher rateof efficacy and lower rate of health risk than related art TPUS and TRUSsystems and methods. Apparatus, systems, and methods disclosed hereinsatisfy these demands.

Other implementations are also described and recited herein. Further,while multiple implementations are disclosed, still otherimplementations of the presently disclosed technology will becomeapparent to those skilled in the art from the following detaileddescription, which shows and describes illustrative implementations ofthe presently disclosed technology. As will be realized, the presentlydisclosed technology is capable of modifications in various aspects, allwithout departing from the spirit and scope of the presently disclosedtechnology. Accordingly, the drawings and detailed description are to beregarded as illustrative in nature and not limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a guide secured to a probe in accordancewith an embodiment;

FIG. 2A shows an internal view of a guide fastener in accordance with anembodiment;

FIG. 2B shows a sheath-based guide fastener in accordance with anembodiment;

FIG. 2C shows a zip-tie-based guide fastener in accordance with anembodiment;

FIG. 3 shows a top view of a guide secured to a probe in accordance withan embodiment;

FIG. 4 shows a cross-sectional view of the back of a guide secured to aprobe in accordance with an embodiment.

FIG. 5 shows a magnified view of a guide secured to a probe inaccordance with an embodiment;

FIG. 6 is a magnified top view of a guide fastener in accordance with anembodiment;

FIG. 7 is a magnified view of a guide in accordance with an embodiment;

FIG. 8 is a side view of a biopsy instrument that has penetrated theprostate in accordance with an embodiment;

FIG. 9 is a front view of a designated area of the prostate where abiopsy instrument will penetrate in accordance with an embodiment;

FIG. 10 is a side view of a biopsy instrument penetrating the prostatein accordance with an embodiment;

FIG. 11 is a front view of a designated area of the prostate where abiopsy instrument will penetrate with areas in which the cell or tissuespecimen has already been extracted in accordance with an embodiment;

FIG. 12 is a top view of a biopsy instrument that has penetrated theprostate in accordance with an embodiment;

FIG. 13 is a side view of a prostate and the path of the biopsyinstrument;

FIG. 14 is a front view of a guide positioned at a designated area ofthe prostate in accordance with an embodiment;

FIG. 15 is a side view of a guide positioned at a designated area of theprostate in accordance with an embodiment;

FIG. 16 is a front view of a guide positioned at another designated areaof the prostate in accordance with an embodiment;

FIG. 17 is a side view of a guide positioned at another designated areaof the prostate;

FIG. 18 is a front view of a guide positioned at a higher designatedarea of the prostate, according to one embodiment;

FIG. 19 is a right side view of a guide positioned at a higherdesignated area of the prostate in comparison with that shown in FIGS.14-17 in accordance with an embodiment;

FIG. 20 is a side view of a guide and a biopsy instrument firmlypenetrating a fat plane and perineum skin of a patient in accordancewith an embodiment;

FIG. 21 is a view of an access needle positioned at the access site inaccordance with an embodiment;

FIG. 22 is a magnified view of the right side of a prostate and a biopsyinstrument in accordance with an embodiment;

FIG. 23 is an image of the front side of a prostate and a biopsyinstrument being retrieved from the prostate, and other targeted areasin accordance with an embodiment;

FIG. 24 shows a method for performing a prostate biopsy in accordancewith an embodiment;

FIG. 25 is an ultrasound image showing a transducer, access needle pathextending from an access point at a perineal site to a prostate, and aprostate;

FIGS. 26A-26C show side views of a guide configured with a pivotingmount in accordance with an embodiment;

FIG. 27 is an isometric front view of another embodiment of a biopsyguide;

FIG. 28 is a front view of the biopsy guide of FIG. 27 ;

FIG. 29 is a side view of the biopsy guide of FIG. 27 ;

FIG. 30 is an isometric front exploded view of the biopsy guide of FIG.27 ;

FIG. 31A is a front isometric view of the upper mount of the biopsyguide;

FIG. 31B is a front view of the upper mount of the biopsy guide;

FIG. 31C is a back view of the upper mount of the biopsy guide;

FIG. 31D is a side view of the upper mount of the biopsy guide;

FIG. 31E is a bottom view of the upper mount of the biopsy guide;

FIG. 31F is a top view of the upper mount of the biopsy guide;

FIG. 32A is a front isometric view of the displacement member of thebiopsy guide;

FIG. 32B is a front view of the displacement member;

FIG. 32C is a back view of the displacement member;

FIG. 33A is an isometric front view of the lower mount of the biopsyguide;

FIG. 33B is a front view of the lower mount;

FIG. 34 is front isometric view of an access needle;

FIG. 35A is a front isometric view of the lower mount;

FIG. 35B is a front isometric view of the lower mount coupled with theupper mount;

FIG. 35C is a front isometric view of the lower mount coupled with theupper mount and the sliding platform engaging with the rails of theupper mount;

FIG. 35D is a front isometric view of the assembly of FIG. 35C with anaccess needle supported by the sliding platform;

FIG. 36 is a front view of another embodiment of the displacementmember;

FIG. 37A is an isometric front view of another embodiment of the biopsyguide;

FIG. 37B is an isometric front exploded view of the upper mount of thebiopsy guide of FIG. 37A;

FIG. 37C is an isometric back exploded view of the upper mount of thebiopsy guide of FIG. 37A;

FIG. 37D is a front view of the upper mount of the biopsy guide;

FIG. 37E is a front isometric view of the displacement member of thebiopsy guide;

FIG. 37F is a front view of the displacement member;

FIG. 37G is a side view of another embodiment of the displacement memberwith the access needle partially positioned within the top needlereceiving port of the vertically extending member;

FIG. 37H is a front isometric view of another embodiment of the a biopsyguide;

FIG. 37I is a side view of the biopsy guide of FIG. 37H showing theplatform member in various positions relative to the probe;

FIG. 37J is a front isometric view of another embodiment of an uppermount;

FIG. 37K is a front view of another embodiment of a biopsy guide;

FIG. 37L is a side view of the biopsy guide of FIG. 37K;

FIG. 37M is a front isometric view of another embodiment of a biopsyguide;

FIG. 37N is a front view of the biopsy guide of FIG. 37M;

FIG. 37O is a front isometric view of a cinch strap;

FIG. 37P is a front isometric view of a V-block insert;

FIG. 37Q is a front view of the biopsy guide of FIG. 37M with a V-blockinsert of FIG. 37P;

FIG. 37R is a front isometric view of another embodiment of a biopsyguide;

FIG. 37S is a front view of the biopsy guide of FIG. 37R;

FIG. 37T is a front isometric view of another embodiment of a biopsyguide;

FIG. 37U is a front view of the biopsy guide of FIG. 37T;

FIG. 37V is a front view of another embodiment of a lower mount;

FIG. 37W is an isometric front view of another embodiment of a lowermount;

FIG. 37X is a front view of another embodiment of a lower mount;

FIG. 38A is a transverse plane or slice view of a prostate depicting theurethra and an access site for penetration of the access needle;

FIG. 38B is a sagittal plane or slice view of the prostate depicting theurethra and an access site for penetration of the access needle;

FIG. 38C is the same transverse plane or slice view as FIG. 38A, butincluding a marking device positioned within the urethra for biopsynavigation; and

FIG. 38D is the same sagittal plane or slice view as FIG. 38B, butincluding a marking device positioned within the urethra for biopsynavigation.

DETAILED DESCRIPTION

The apparatus, systems, and methods provided herein enable real-timevisualization, free-handed, guided, and multi-sample transperinealmethods for performing a biopsy. The methods, systems, and apparatusprovided herein also enable a complete biopsy of the prostate with onlyone perforation, or with minimal perforations of a patient's skin by wayof an initial access site, such that the access needle is freelymoveable. The biopsy guide may be placed on or fitted to an assortmentof ultrasound probes of different sizes and shapes due to an adjustablemounting system. The guide may be configured to fit to the probe usingany suitably configured fastening system. For example, the guide may beconfigured as a sleeve that is formed to slide over an end of a probeand into an operable position. Alternatively, the guide may beconfigured to fit to a probe using screws, flanges, zip ties, or othertemporary, permanent, or semi-permanent fastening systems.

In one embodiment, the guide allows biopsies of one or more tissue orcell samples to be obtained through an initial access needle, whileproviding direct, real-time ultrasound visualization by, for instance,fixing a position of the access needle relative to an ultrasound probeto provide. For example, the guide is fixed to an ultrasound probe thatis not fixed and may be freely moveable in operation. Stabilization barsthat are built into the guide facilitate the positioning and holding ofthe perineal skin and subcutaneous tissue to allow positioning of theaccess needle. The position of the access needle is facilitated bylocking the access needle into the subcutaneous tissue of the perineumusing a sliding platform that allows a user, such as a medicalpractitioner or patient caregiver, to place the access needle along asagittal transducer plane at optimal positions for obtaining prostatebiopsies. In some embodiments, upon placement of the access needle intoa locked position, for example, in the pelvic floor, a user may thenpass a biopsy needle through the access needle to a desired location ofthe prostate. In yet further embodiments, the passing of the biopsyneedle through the access needle and to the prostate may be facilitatedby direct sagittal plane visualization based on the alignment of theaccess needle.

Methods and systems provided herein do not require a patient to takeantibiotics at any point prior to the biopsy procedure, nor do theyrequire a patient to undergo bowel preparation in advance of theprocedure. Methods, systems, and apparatus can reduce or eliminatemultiple skin perforations by using a single access location or accesssite, while allowing multiple extractions of tissue or cell specimensfrom the prostate. Methods, systems, and apparatus in accordance withembodiments allow for real-time visualization during a free-handed,guided, transperineal approach, while also facilitating a completeassessment of the prostate with, for example, only one perforation ofthe patient's skin wherein the access needle is freely moveable in eachplane.

Methods, systems, and apparatus of embodiments may include andfacilitate treatment that uses a cryoablation probe for focal therapy ofprostate cancer, a radiofrequency instrument, a thermotherapyinstrument, any instrument for treatment of the cancerous area, or acombination of any of these instruments.

Methods, systems, and apparatus of embodiments enable planning andperforming the free-hand transperineal prostate biopsies under theguidance of a device and of a real-time transducer in the sagittalimaging plane.

The biopsy is performed using a system that includes a biopsy guide, atransducer, an access needle, and a biopsy instrument. The access needlemay allow the anesthesia to be injected into the patient, and the tissueor cell specimens of the prostate to be extracted. If anesthesia isused, a syringe may be included in the system. The transducer may be anultrasound probe or any other type of device that is capable of causinga visualization of the prostate in a display device. In embodiments, thebiopsy guide may be disposable. In embodiments, the biopsy guide may beformed of materials intended for a single use. In other embodiments, thebiopsy guide is reusable. In some embodiments, the biopsy guide may beformed of materials intended for multiple uses.

The guide may include a sliding platform, stabilization bars, one ormore upper and lower mounts, and a fastener. The upper and lower mountsmay be curvilinear in shape. The upper and lower mounts may bepositioned proximally or distally along an ultrasound probe, such as atransrectal ultrasound probe. The configuration and positioning of theupper and lower mounts are adjustable based on the shape of theultrasound probe and the patient's body habitus.

The guide may be made of any material such as a plastic or metallicmaterial. The guide may be disposable and made of a biodegradableplastic material. In other embodiments, the guide may be reusable andmade of stainless steel. The dimensions, for example, the length, width,height, depth, and breadth of the sliding platform, stabilization bars,upper and lower mounts, and the fastener may vary and may be adjustable.The variable and adjustable dimensions, for example, of thestabilization bars, provide a user with flexibility in achieving andmaintaining the guide in an appropriate ultrasound plane whileperforming biopsy procedures, while the user's patients may vary in sizeand levels of perineal subcutaneous tissue and fat. In a patient with anexcessive amount of perineal subcutaneous tissue and fat, a largerstabilization bar will assist in locking the guide in the properultrasound plane.

The adjustable stabilization bars and mounts may be curvilinear inshape, allowing the guide to be placed proximally or distally along anycylindrical instrument, such as the transrectal ultrasound probe, whichis determined by the surgeon based on the shape of the probe and thepatient's body habitus. This allows the guide to be mounted to anyassortment of ultrasound probes. Similarly, the platform may, forexample, have various thicknesses.

The stabilization bars may be fixed to a top portion of the uppercurvilinear mounts of the guide, and may extend beyond the front edge ofthe upper mounts. The stabilization bars may extend beyond the frontedge of the upper curvilinear mount by approximately 8 mm. The guide maybe approximately 60 mm wide, or the guide may be approximately 50 mmlong, for example. The stabilization bars may have grooves foraccommodating a sliding platform that is shorter in length than thestabilization bars. The grooves being configured to allow the platformto slide forward and backward along the stabilization bars.

An inner portion of the stabilization bars may have built-in grooves.The grooves accommodate a sliding platform which is shorter in lengththan the stabilization bars. This allows the sliding platform to slidefrom the back to the front of the stabilization bars. The stabilizationbars may include a resistance as to prevent the sliding bar to freelymove back and forth on the stabilization bar. This resistance may beintroduced by the sliding platform or both the stabilization bar and thesliding platform. The resistance may be provided by a strip of rubber orany other material capable of providing friction or other. The strip maybe curvilinear. The resistance may be generated by a mechanical system,such as a spring mechanism.

The sliding platform may have a hole through the platform. In someembodiments, the hole is drilled in the center of the platform. The holecan accommodate various types of needles, including access needleshaving various diameters, for example, spinal needles having a gauge inthe range of 14-18. The hole can also accommodate needles having variouslengths. The lengths of the needle may depend, in part, on the bodyhabitus. The needle may be a reusable needle, such as a reusable spinalneedle. The needle may be a disposable needle, such as a disposablespinal needle.

A flange of the guide secures the placement of the access needle to theguide. The flange may be configured to snap into the guide to secure theneedle. The flange may be secured to the guide by other securingmechanisms. The flange can be of various shapes and configurations. Forexample, the flange may be u-shaped. As another example, the flange mayhave a thin or slim configuration. The guide assists in providing theappropriate angle of penetration and direction of the access needle, orother instruments that may be used in combination with the guide.

The hole in the guide is placed so that once the guide is mounted to theultrasound probe, the drilled hole will be parallel to the sagittaltransducer. The drilled hole may also accommodate the tip of a biopsygun, or any other biopsy instrument. The sliding platform may beinterchangeable and may be removed to allow placement of another slidingplatform with a different sized to permit different sizes of needles andother instruments. The hole may be configured to accommodate acryoablation instrument, a radiofrequency instrument, thermotherapyinstrument, or any other instrument for diagnosis and treatment of abodily tissue, including a cancerous area of a prostate.

The platform may have or define a predrilled hole in the center of theplatform that can accommodate various sizes of needles and instruments.For example, the hole may be configured to accommodate a needle having arange of 14-18 gauges, such as a reusable 14 gauge spinal needle.Central hole placement on the platform enables alignment of the holewith a sagittal transducer when the guide is mounted to an ultrasoundprobe. The platform may have multiple holes to accommodate variousapplications and body habitus. Further, the platform may be of variousthicknesses.

Once the one or more upper curvilinear mounts are placed at the desiredlocation on the transrectal ultrasound probe, the access hole for aneedle, such as a 14 gauge reusable spinal needle, will remain a fixeddistance from the ultrasound probe. In embodiments, having one or morelower curvilinear mounts, the mounts may be positioned to cradle anupper aspect of the ultrasound probe.

At least two lower mounts are provided and may be individuallypositioned to accommodate various types of probes, which may havevariable diameters along their shafts. In embodiments, a probe, such asa transrectal ultrasound probe, may have one or more diameters along theprobe's shaft. In yet further embodiments, one end of the guide may befixed at a location of the probe having a different diameter than thelocation where the other end of the guide is fixed. The separate lowermounts allow for the fixation of the guide, even with varying probediameters.

The lower mount of the guide may include a lower right mount and a lowerleft mount connected by an adjustable mid-joint or fastener. Theadjustable mid-joint or fastener allows the guide to be secured to theprobe even if the diameter of the shaft of the probe is longer than thewidth of the lower mount. The mid-joint or fastener may be flexible toallow the right lower mount to form an acute angle with the left lowermount. This also allows for fixation of the guide to a probe shaft thatis not circular in shape.

The lateral edges on both ends of the lower mounts may contain a notchedpost. Corresponding locations of the upper mounts contain holes, such assquare shaped holes, to accommodate the notched post of a correspondinglower mount. An upper aspect of each hole includes a flange for lockingthe notched post in a fixed position. This configuration allows thelower mounts and the upper mounts to be secured to each other and to theprobe.

Methods may include locating a suspicious area, positioning an accessneedle, and obtaining one or more tissue or cell specimens from anaccurate point in the prostate. The method allows for multiple tissue orcell specimens to be obtained from a bodily organ, such as the prostate,and permits access to the prostate from different angles through asingle initial access needle. The method may include calculating thevolume of the prostate by positioning the access needle at a mid-pointin the x axis from the lateral edge of the prostate to the urethra.

Methods may be performed using no anesthesia. Alternatively, ananesthetic may be used. For example, the anesthetic may be lidocaine, orany type of local anesthetic. The lidocaine may include 1 or 2% of alidocaine solution.

The suspicious area or bodily organ may be located by using atransducer. The transducer may be any type of probe for accessing andviewing a targeted site or object, such as an ultrasound probe, or anytype of transducer capable of providing visualization of the prostateand/or instruments and devices for diagnosis and treatment of thetissue. The biopsy may be performed using a biopsy gun, a suctiondevice, or any type of instrument that is small enough to be introducedthrough the access needle and capable of extracting the tissue or cellspecimen. The biopsy may be performed while the patient is in a dorsallobothy position, prone position, or any position that allows for accessto the perineal area.

Methods may include applying an antiseptic solution to the perinealarea. The antiseptic solution may include betadine, or any othersubstance that reduces the possibility of infection, sepsis, orputrefaction. Methods may include applying bacitracin to the skin at thepuncture site or any other type of topical preparation for preventingthe possibility of infection.

Methods may include attaching a needle to a luer lock syringe, which maycontain an anesthetic, or any other type of device capable of retainingits contents and dispensing its contents through the needle. A biopsygun or any other instrument that may be attached to the needle and usedfor inserting or extracting any substance thru the lumen of the accessneedle.

Methods may include releasing the syringe from the needle after theanesthetic is injected. Methods may include dividing the prostate inthree different regions and designating lateral, mid, apical prostate,and may include labeling the tissue or cell specimen containers, whichwill identify the tissue or cell specimens.

Methods may include securing the guide to the probe. This will permitthe practitioner to take the biopsy gun as many times as necessary usinghis/her other hand, and, consequently, extract multiple tissue or cellspecimens. It is contemplated that this can be done without assistanceof any other person, and that the biopsy gun may also be attached to theguide in order to permit the surgeon to, for example, label thecontainer with the tissue or cell specimen while performing the biopsy.Methods may also include monitoring all the actions in the prostate byway of a display device that provides images captured by the probe.

Methods may include moving the needle in x, y, and z planes. By beingable to move the needle in x, y, and z planes, the surgeon is capable ofextracting tissue or cell specimens from several different areas of theprostate without having to retrieve the needle and preventing otherperforation of the patient's skin. In embodiments, movement of theneedle within the patient's body is facilitated by using a displaydevice.

Methods may include removing the access needle from the perineal area.This may be done while the biopsy gun is secured to the access needle orafter the biopsy gun has been detached from the access needle.

Methods may include realigning the needle in the desired prostateregion. If the surgeon wishes to start at the right lateral prostateregion and notices that the needle tip is not directed at the lateralregion, the surgeon rolls the ultrasound probe slightly and to note thatthe needle tip is directed to the desired region, then the surgeon mayrealign the needle to obtain tissue or cell specimen. The surgeon mayrealign the needle using one hand while having the needle attached tothe biopsy gun, which may be attached to the probe through the guide.

Methods may include identifying the areas in which biopsy have alreadybeen performed. After each extraction of tissue or cell specimen duringthe biopsy, a hyperechoic streak remains visible on ultrasound display.This allows the surgeon to identify the area of the prostate and that anextraction has been made, as to allow the surgeon to prevent overlap ofextractions.

In another embodiment, the method includes identifying the path of theurethra. This allows the surgeon from preventing passing the biopsyneedle thru or into this path.

FIG. 1 is a side view of a guide 100 secured to a probe including astabilization bar 101, fasteners 102, probe 103, lower mounts 104, andan upper mount 105. The stabilization bar 101 is an extension of theupper mount 105, as further discussed in FIG. 4 . In embodiments, thedistance between the fasteners 102 and the upper mount 105 may beadjustable to accommodate various applications and body habitus.

FIG. 2A is an internal view of a guide's fastener, including an aperture201, teeth 202, and a flange 203. The flange 203 may be an extension ofthe aperture 201, which is part of the upper mount 105. Aperture 201will allow the teeth 202 to be inserted into the upper mount 105, andthe flange 203 will lock the teeth 202, which is connected to lowermount 104, to the upper mount 105. The aperture 201 with flange 203 andteeth 202 allows for adjusting the height of the guide 100.

In one embodiment, the fastener (e.g., via the aperture 201, flange 203,and/or the teeth 202) can be configured to fasten the guide 100 to theprobe 103 with, e.g., varying levels of tension to provide foradjustments of the relative positions of the guide 100 and the probe 103even after the guide 100 has been mounted to the probe 103. For example,the fastener 102 can provide a first level of tension sufficient to holdthe position of an access needle (e.g., introduced through a hole orother needle mount of the guide 100) rotationally fixed to the probe 103while still allowing for a forward or reverse sliding of the probe 103with respect to the guide 100. By way of example, the forward or reversesliding adjustment can be performed to adjust the penetration depth ofthe probe 103 with respect to the patient depending on a size of thepatient. Once the final adjustment is made, the fastener can be actuatedto final position or tension that will then lock further adjustments ofthe positioning of the guide 101 relative to the probe 103.

It is noted that the guide's fastener as described above is one exampleembodiment among other possible example fasteners that are applicable tovarious embodiments of the guide 100. Accordingly, it is contemplatedthat various embodiments of the guide 100 may use any now known or laterdeveloped fastening system that can secure the guide 100 to the probe103.

By way illustration and not limitation, examples of two fasteners arediscussed with respect to FIGS. 2B and 2C. FIG. 2B shows a sheath-basedfastener whereby the fasteners 102 are attached to a sheath 211 that isconfigured to slide over an end of a probe 103 and into an operableposition. Although the sheath 211 is shown as a closed sheath, inanother embodiment, the sheath 211 can be configured as a sleeve that isopen-ended to slide over the probe 103. By way of example, the sheath211 can be made of a flexible material (e.g., rubber) to provide forstretching and tension on probe 103.

In another embodiment, as shown in FIG. 2C, the guide 100 can beconfigured with a zip-tie style fastener in place of a lower mountmechanism to secure the guide 100 to the probe 100. In other embodiments(now shown), the guide 100 may be configured to fit to the probe 100using screws, flanges, or other temporary, permanent, or semi-permanentfastening systems. In addition, although the fasteners 102 of the guide100 may be configured as generic and adjustable fasteners that cansupport probes of a variety sizes and shapes, it is also contemplatedthat the fasteners can be fit to specific models of probes forcustomized applications.

FIG. 3 is a top view of a guide secured to a probe. This figure includesa sliding platform 301, a drilled hole 302, stabilization bars 101,fasteners 102, an upper mount 105, and a probe 103. As previouslydescribed, in one embodiment, the drilled hole 102 can accommodate orsupport various sizes and/or configurations of needles (e.g., straightneedles, curved needles, etc.) and instruments for performing a biopsyso that the needle can be aligned relative to the probe 103, thereby,also providing an alignment between the needle and an image produced bythe ultrasound probe 103. In one embodiment, the drilled hole 102 cansupport an access needle through which a biopsy needle or otherinstrument can be introduced at a known alignment with respect to theprobe 103. In addition, although the hole 102 to support, e.g., anaccess needle or other instrument is showed in a central midlineposition, the location of the hole can be configured at any position ofthe guide 100.

FIG. 4 is a cross-section view of the back of a guide secured to a probeincluding a sliding platform 301, drilled hole 302, stabilization bars101, lower mount 104, upper mount 105, fasteners 102, and probe 103.

FIG. 5 is a magnified view of FIG. 1 . FIG. 5 demonstrates minimumdimensions of preferred embodiments, which includes stabilization bars101 and upper mount 105 from 30 mm to 50 mm long; the upper mount 105with a height ranging from 10 mm to 15 mm; the stabilization bars 101with a height that is about ⅓ of the height of the upper mount 105;fasteners 102 with a height of about 25 mm and 10 mm wide; a lower mount104 10 mm wide. Additionally, the offset 501 from the distal point ofthe stabilization bar 105 to the fasteners 102 may be 5 mm. It iscontemplated that any of these dimensions may vary, including thestabilization bar 101, which may be longer than the upper mount 105.

FIG. 6 is a magnified internal view of the guide fastener shown in FIG.2 . FIG. 6 demonstrates minimum dimensions of preferred embodiments. Thefasteners 102 may have an aperture 201 to accommodate teeth 202, whereinthe fastener 102 is 5 mm to 10 mm wide. Additionally, the slidingplatform 301, which may be from 12 mm to 25 mm wide, is slightly shorterthan the distance between the two stabilization bars 101 as toaccommodate the sliding platform while also securing it to the guide100.

FIG. 7 is a magnified view of the guide depicted FIG. 3 , without theprobe 103. FIG. 7 also demonstrates minimum dimensions of preferredembodiments, wherein the height of the upper mount 105 ranges from 5 mmto 10 mm; and the teeth 202 is from 5 mm to 8 mm wide.

FIG. 8 is a side view of a biopsy instrument that is about to penetratethe prostate, including a prostate 801, a probe 103, a biopsy instrument802, a perineum skin 803, an anus 804, and a perforation point 805. Theprobe 103 is inserted into the anus 804 to provide real-time images ofthe biopsy, including images of the biopsy instrument 802 and theprostate 801. It is contemplated that the biopsy instrument 802 includesa needle and any other instrument capable of performing a biopsy.

FIG. 9 is a front view of a targeted area 902 of the prostate 801. FIG.10 is a side view of a biopsy instrument penetrating the prostate 801,including a targeted area 902 of the prostate 801. The targeted area 902is reached by biopsy instrument 802 after perforating perineum skin 803.

FIG. 11 is a front view of a targeted area of the prostate where abiopsy instrument will penetrate with areas in which the cell or tissuespecimen has already been extracted. FIG. 11 depicts both an extractedarea 1101 and a targeted area 902. The possibility of viewing the areain which the cell or tissue specimen has already been extracted permitsthe practitioner to avoid placing the access needle in an area that cellor tissue specimen has already been extracted. This allows the biopsy tobe more efficient and more accurate.

FIG. 12 is a top view of FIG. 8 , depicting a prostate 801, perineumskin 803, a probe 103, and a biopsy instrument 802. FIG. 13 is a rightside view of a prostate and the path of the biopsy instrument includingthe path of the biopsy instrument 1301 and the perforation point 805.FIG. 13 illustrates that only one initial perforation to the skin of thepatient is necessary in order to extract one or more cell or tissuespecimens.

FIG. 14 is a front view of a guide determining a lower targeted orsuspicious area 1401 of the prostate in which to penetrate the biopsyinstrument, a prostate, and a probe. FIG. 16 is a front view of a guidedetermining a mid-target or suspicious area 1601 of the prostate inwhich to penetrate the biopsy instrument, a prostate, and a probe. FIG.18 is a front view of a guide determining a higher targeted orsuspicious area 1801 of the prostate in which to penetrate the biopsyinstrument, a prostate, a probe. FIGS. 14, 16, and 18 demonstrates thevariety of angles and positions in which a guide may be positioned inorder to reach several regions of the prostate, such as the lateralregion, mid region, and apical region. In order to the able to reachthese areas, FIGS. 14,16, and 18 demonstrate how the upper mount 105,the stabilization bars 101, or a combination of thereof can adjust inorder to reach a lower targeted or suspicious area 1401, a mid-targetedor suspicious area 1601, or a higher targeted or suspicious area 1801 ofthe prostate.

FIGS. 15, 17, and 19 demonstrate a side view of FIGS. 14, 16, and 18 andthe paths of the biopsy instrument 1301 taken by a biopsy instrument toreach lower targeted or suspicious area 1401, a mid-targeted orsuspicious area 1601, or a higher targeted or suspicious area 1801 ofthe prostate.

FIG. 20 is a right side view of a guide, and a biopsy instrument firmlypenetrating a fat plane of perineum skin, including offset 501 of astabilization bar 101. This allows for stabilization in a patient withan excessive amount of perineal subcutaneous tissue, fat, or acombination thereof. A larger stabilization bar 101 will assist inlocking the guide in the proper ultrasound plane. Accordingly, theoffset 501 may longer than 5 mm for these purposes.

FIG. 21 is a front view of a prostate, a probe, a targeted or suspiciousarea, wherein the biopsy instrument may reach any area of the prostate.FIG. 21 demonstrates that the biopsy instrument can reach the entireprostate while using only one perforation point 805. After obtaining onecell or tissue specimen, the biopsy instrument 802 may be partiallyretrieved from the perineum area at a point in which the distal point ofthe biopsy instrument 802 is redirected to another targeted orsuspicious area. Then, the biopsy instrument (usually the needle of thebiopsy instrument) is inserted to the second targeted or suspicious areafor obtaining a cell or tissue specimen of another area of the prostate.

FIG. 22 is a magnified view of the right side of a prostate and a biopsyinstrument. FIG. 22 depicts the location of the biopsy instrument insidethe prostate and the other paths in which the biopsy instrument may takeutilize for additional samples or retrieval. In embodiments, the biopsyneedle or other instruments do not reach the initial part of the penis,which is in a different plane from the prostate.

FIG. 23 is an image of the front side of a prostate and a biopsyinstrument being retrieved from the prostate, and other targeted areas.FIG. 23 shows a procedure being applied to the apical region of theprostate.

The urethra should be avoided in any part of the procedure, but it ismostly important when extracting cell or tissue specimens from theapical region of the prostate, when the chances of perforation isgreater. After several extractions, the practitioner is able to see theblood streak from where the cell or tissue specimen was taken so as toavoid overlapping.

After this procedure, the patient may be put with restriction for nomore than 1 day. If the patient is put on restriction for 1 day, afterthe one-day-restriction, no restriction is made.

In an embodiment, the biopsy system performs the processes 2400 of FIG.24 . At 2401, a patient is prepared for the biopsy procedure by havingthe patient get into a lithotomic position, prone position, or anyposition that allows for access to the perineal area. The biopsyprocedure may be a prostate biopsy. In some embodiments, the patient'sscrotum is elevated using, for example, two strips of plastic tape. Theperineum is prepared with an antiseptic solution to the perineal area,for example, the antiseptic solution may include betadine.

At 2402, a target area or object, such as the prostate, is imaged.Imaging may be performed with a transducer, such as an ultrasound probe.Imaging of a target area may be in a sagittal and/or axial plane and maybe performed in real-time with direct visualization. Utilizing thereal-time image, a user can identify areas of interest, e.g. suspiciousareas or the target area or object at 2403.

The user may determine an access site for positioning an access needle.At 2404, an access needle is positioned at an access site insubcutaneous tissue of the perineum. The access site may be at amidpoint between a lateral edge of the prostate and the urethra along anx axis, and a midpoint between an anterior capsule and a posteriorcapsule along a y axis. The access needle is guided and positioned atthe access site by using the guide.

At 2405, a biopsy instrument is guided to the target or suspicious areasor object. The biopsy instrument may include a biopsy needle. Theguiding of the biopsy instrument can be facilitated by using thereal-time visualization provided by the transducer. Real-timevisualization also facilitates obtaining tissue or cell specimens froman accurate point in the prostate, for example. The method allows forone or more tissue or cell specimens to be obtained from a bodily organ,such as the prostate at 2406, and permits access to the prostate fromdifferent angles through a single initial access needle.

At 2407, the biopsy instrument may be retrieved and removed from thepatient. The method may include calculating the volume of the prostateby positioning the access needle at a mid-point in x axis from thelateral edge of the prostate to the urethra.

FIG. 25 shows an ultrasound 2501 showing a transrectal probe 2503 and anaccess needle guide line 2505. The needle guide line enables thepractitioner to observe a needle path whereby the access needle hascontacted the prostate 2507, thereby enabling the practitioner to avoidoverlapping sampling, and to avoid perforating the prostate.

FIGS. 26A-26C show side views of an alternative embodiment of a guide2600 secured to a probe including a stabilization bar 101, fasteners102, probe 103, lower mount 104, and an upper mount 105. Thestabilization bar 101 is an extension of the upper mount 105, as furtherdiscussed in FIG. 4 . In embodiments, the distance between the fasteners102 and the upper mount 105 may be adjustable to accommodate variousapplications and body habitus.

The guide 2600 includes a sliding platform 301. The guide is fitted tothe probe 103 by a sleeve 2607. The sleeve 2607 is formed by the lowermount 104 and the upper mount 105. The sleeve 2607 may be configured toslide over an end of the probe 103 into an operable position as shown inFIGS. 26A-26C. The sleeve 2607 is a partial sleeve that has an openingat both ends of the sleeve 2607 to enable slidable mounting to andremoval from the probe 103.

The sliding platform 301 of the guide 2600 may be pivotably mounted toenable movement in a direction perpendicular to a longitudinal axis ofthe probe 103, as shown in FIGS. 26A-26C. In particular FIGS. 26A-26Cshow that the sliding platform 103 is fixed to the guide at a pivotpoint 2608. The sliding platform 103 is configured to pivot at pivotpoint 2608 to enable, for example, normal or vertical adjustment of anaccess needle (not shown) in directions perpendicular to a longitudinalaxis of the probe 103 while ensuring that a longitudinal axis of theaccess needle (not shown) remains parallel to the longitudinal axis ofthe probe 103.

For example, FIG. 26A shows a sliding platform 301 in a first positionat which a lateral planar surface of the platform 301 extends in adirection parallel to the longitudinal axis of the probe 103. FIG. 26Bshows the sliding platform 301 pivoted to a second position wherein afront end the platform 301 is disposed a distance from the probe 103that is greater than a distance between an opposite rear portion of theplatform 301 and the probe 103. FIG. 26C shows the sliding platform 301pivoted to a third position wherein the rear end of the platform 301 isdisposed a distance from the probe 103 that is greater than a distancebetween the opposite front end of the platform 301 and the probe 103.

In another embodiment, the method may be performed without the patienttaking antibiotics or undergoing bowel preparation before having theprocedure. During the procedure, the practitioner may administer ananesthetic to the patient, for example, lidocaine, or any type of local,anesthetic. The lidocaine may be included in a solution having 1% oflidocaine.

In an embodiment, the suspicious area is located by using a transducer.The transducer may be any type of transrectal robe for prostate cancer,such as an ultrasound probe, or any type of transducer capable ofimaging the prostate and the extraction device. The biopsy may beperformed using a biopsy gun, a suction-mechanism, or any type ofinstrument that is small enough to be introduced through the accessneedle and capable of extracting the tissue or cell specimen. The biopsymay be performed while the patient is in a lithotomy position, proneposition, or any position that allows for access to the perineal area.

In another embodiment, methods may include applying an antisepticsolution to the perineal area such as betadine, or any other substancethat reduces the possibility of infection, sepsis, or putrefaction.

In another embodiment, the ultrasound probe may be a B&K 8848transrectal ultrasound probe, or any other ultrasound capable of causingvisualization of the prostate and the extraction device. The frequencyrange may be 5-12 MHZ, and the focal range may be 3-60 mm. Theultrasound probe may be able to cause the visualization of the prostateand extraction devices at least in the axial plane, sagittal plane, or acombination thereof.

In another embodiment, methods may include attaching a needle to a luerlock syringe, which may contain an anesthetic, or any other type ofdevice capable of retaining its contents and to dispense its contentsthrough the needle. A biopsy gun or any other instrument may be attachedto the needle for inserting or extracting any substance through thelumen of the access needle.

In another embodiment, the method includes releasing the syringe fromthe needle after the anesthetic is injected. The method may includedividing the prostate in three different regions and designatinglateral, mid, apical prostate, and may include labeling the tissue orcell specimen containers, which will identify the tissue or cellspecimens.

In another embodiment, a biopsy gun may be an 18 gauge biopsy gun, orany other size that is capable of being coaxially inserted thru thelumen of the access needle.

In another embodiment, methods may include securing the guide to theprobe. This will permit the practitioner to take the biopsy gun as manytimes as necessary using his or her other hand, and, consequently,extract multiple tissue or cell specimens. It is contemplated that thiscan be done without assistance of any other person, and that the biopsygun may also be attached to the guide in order to permit the surgeon toe.g. label the container with the tissue or cell specimen whileperforming the biopsy. The method may also include monitoring all theactions in the prostate thru a display device, which will transmitimages captured by the probe.

In another embodiment, methods may include moving the needle in x, y,and z planes. By being able to move the need in x, y, and z planes, thesurgeon is capable of extracting tissue or cell specimens from severaldifferent areas of the prostate without having to retrieve the needleand preventing other perforation of the patient's skin.

Methods may further include removing the access needle from theperennial area. Removal of the access needle may be performed while thebiopsy gun is secured to the access needle or after the biopsy gun hasbeen detached from the access needle.

Methods may include realigning the needle in the desired prostateregion. If the surgeon wishes to start at the right lateral prostateregion and notices that the needle tip is not directed at the lateralregion, the surgeon rolls the ultrasound probe slightly and to note thatthe needle tip is directed to the desired region, then the surgeon mayrealign the needle to obtain tissue or cell specimen. The surgeon mayrealign the needle using one hand while having the needle attached tothe biopsy gun, which may be attached to the probe through the guide.

Methods may include identifying the area in which a biopsy has alreadybeen performed. After each extraction of tissue or cell specimen duringthe biopsy, a hyperechoic streak remains visible on ultrasound display.This allows the surgeon to identify the area of the prostate and that anextraction has been made, as to allow the surgeon to prevent overlap ofextractions.

In another embodiment, methods may include identifying the path of theurethra. This allows the surgeon from preventing passing the biopsyneedle thru or into this path. In another embodiment, the methodincludes pressuring the perineum. In yet another embodiment, the methodincludes applying bacitracin to the skin at the puncture site or anyother type of topical preparation for preventing the possibility ofinfection. In another embodiment, positioning the access needle isperformed without the need of a biopsy grip, wherein the guide providesthe precise point for the biopsy.

An apparatus and system in accordance with embodiments discussed aboveis used to carry out these methods. In an alternative embodiment ofapparatus and systems, a guide may not include a lower mount, and mayinclude an access needle. The guide includes a stabilization bar,sliding platform, a hole located in approximately the center of theplatform, an upper mount, teeth, aperture, arms, and a connector. Theaccess needle includes a hub and is secured to the guide. The teeth maybe part of, or may be attached to, a lower mount. The teeth may beinserted into the aperture in order to secure the guide to a probe, forexample. It is contemplated that the combination of the aperture and theteeth may form a fastener mechanism. In embodiments, connector is partof, or may be attached to, an access needle, and may be secured to theupper mount in order to provide stabilization of the access needle andto allow the practitioner to move the access needle by merely moving,for example, a probe that may be secured to the guide.

A connector and a hub permit the use of various other instruments suchas, for example, a non-biopsy instrument, to be secured. A biopsyinstrument may be inserted into the access needle in order to reach atargeted area. The upper mount may include arms. In embodiments, thearms may be shorter, longer, or may not exists, in which case theaperture is disposed directly in the upper mount. When the aperture isdirectly in the upper mount, upper mount may be longer, thicker, or acombination thereof.

In some embodiments, the guide may include lower mounts that have teeth.Arms may extend from the upper mount to allow the height of the guide tobe adjusted and to be placed farther from or closer to the probe. Thearms permit the access needle to be maintained at a certain distancefrom a probe. In embodiments, the material of the guide may be a plasticor any other material, including other plastic materials, or any othermaterial that is cost effective. In embodiments, the guide may bereusable and may be formed with a stainless steel. The lower mount maybe curvilinear and flexible to allow the lower mount to bend ifnecessary to secure the guide to the probe.

Reference is made to FIGS. 27-35D, which depict various views of anotherembodiment of a transperineal biopsy guide 2700. As with the previouslydescribed embodiments, the biopsy guide 2700 may couple with atransrectal probe and may be used in guiding an access needle in atransperineal prostate biopsy procedure. While reference will be made tothe embodiment in FIGS. 27-35D, aspects of the previously describedembodiments may be incorporated into the present embodiment withoutlimitation. And, aspects of the present embodiment may be similarlyincorporated into the previously described embodiments withoutlimitation.

To begin, reference is made to FIGS. 27-30 , which depict, respectively,a front isometric view, a front view, a side view, and a front isometricexploded view of the transperineal biopsy guide 2700. As seen in thefigures, the biopsy guide 2700 includes an upper mount 2702 and a lowermount 2704. The lower mount 2704 includes a probe coupling or fasteningmechanism 2706 to couple the lower mount 2704 with a transrectal probe(not shown in FIGS. 27-28 , but shown in FIGS. 1, 2B, and 3-6 , forexample). The lower mount 2704 additionally includes an upper mountcoupling mechanism 2714 to couple the lower mount 2704 with the uppermount 2702. While FIGS. 27-30 depict a single coupling mechanism 2706,it is foreseen that the biopsy guide 2700 may include more than onecoupling mechanism 2706, as shown and described in previous embodiments.

The upper mount 2702 may couple with the lower mount 2704 and mayinclude a guide member 2708 and a displacement member, translatingmember, or sliding platform 2710. The displacement member 2710 maycouple with an access needle 2712 and be supported by the guide member2708. More particularly, the displacement member 2710 may slidinglycouple with the guide member 2708 such that the displacement member 2710and the access needle 2712 are guided along a trajectory that is fixedrelative to the guide member 2708 and the transrectal probe. Thetrajectory of the access needle 2712 may be generally parallel with alongitudinal axis of the transrectal probe when the biopsy guide 2700 iscoupled with the probe.

Reference is made to FIGS. 31A-31F, which depict various views of theguide member 2708 of the upper mount 2702 of the biopsy guide 2700. FIG.31A is a front isometric view of the guide member 2708; FIG. 31B is afront view of the guide member 2708; FIG. 31C Is a back view of theguide member 2708; FIG. 31D is a side view of the guide member 2708;FIG. 31E is a bottom view of the guide member 2708; and, FIG. 31F is atop view of the guide member 2708.

As seen in the figures, the guide member 2708 includes a distal end2716, a proximal end 2718 opposite the distal end 2716, and alongitudinal axis 2720 extending through the distal and proximal ends2716, 2718. As described herein locational orientations of distal andproximal are relative to the patient or, more particularly, the perineumof the patient. As such, distal generally refers to towards the patientand proximal refers to away from the patient.

Referring back to the figures, the guide member 2708 further includes abase platform 2722 extending substantially perpendicularly between apair of vertical extension members 2724. Atop each of the verticalextension members 2724 is a guide rail or stabilization bar 2726 that isadapted to slidingly engage with and allow the displacement member 2710to translate along a trajectory that is parallel with the longitudinalaxis 2720 of the guide member 2708.

As best seen in FIGS. 31A and 31C, each of the guide rails 2726 includesa generally rectangular member 2728 that is perpendicularly oriented tothe vertical extension members 2724. The rectangular member 2728 extendsfrom the proximal end 2718 to the distal end 2716 of the guide member2708. The vertical extension members 2724 couples with a bottom surface2730 of the rectangular member 2728. An outer lateral edge of therectangular member is coupled with a side member 2732 that extends fromthe proximal end 2718 to the distal end 2716 of the guide member 2708. Adistal member or flange 2734 extends inwardly from the rectangularmember 2728 a distance that is equal to the width of the rectangularmember 2728. More particularly, the distal member 2734 includes arounded inner edge 2736 that is coplanar, at its apex, with an inneredge 2738 of the rectangular member 2728. The distal member 2734 mayinclude a planar distal face or surface 2740 with an opening 2742 formedtherein. The opening 2742 may facilitate an access point for injectionmolding. As with previously described embodiments, the guide rails 2726and, more particularly, the distal face 2740 of the guide rails 2726 mayfacilitate the positioning and holding of the perineal skin andsubcutaneous tissue to allow positioning of the access needle 2712.

As seen in FIGS. 31A, 31C, and 31F, a top surface 2744 of therectangular member 2728 includes a stop feature 2746 to secure or lockthe displacement member 2710 in a distal or deployed condition orposition. The stop feature 2746 is a ramp that distally slopes upwarduntil the apex of the ramp at which point the ramp distally slopesdownward. In the distal position, the displacement member 2710 is at adistal-most position and abuts or is adjacent a proximal face 2748 ofthe distal member 2734. The distal member 2734, thus, prevents furtherdistal movement of the displacement member 2710 and the stop feature2746 restrains proximal movement a certain amount. In certainembodiments, as seen in the figures, the proximal end 2718 of therectangular member 2728 is open such that the displacement member 2710can be slidingly engaged with the rectangular member 2728.

As seen in FIGS. 31A and 31D-31F, the base platform 2722 extends aboutone half of the overall longitudinal distance of the guide rails 2726.In this way, the guide rails 2726 extend beyond both the base platform2722 and the vertical extension members 2724 such that the guide rails2726 may contact the perineal skin and subcutaneous tissue of thepatient but not a distal edge 2750 of the base platform 2722 or a distaledge 2752 of the vertical extension members 2724. And since a distalportion of the lower mount 2704 lies generally flush with the distaledge 2750 of the base platform 2722, the lower mount 2704 also may bespaced apart from the skin of the patient during the biopsy procedure.In this way, in certain embodiments, the guide rails 2726 may contactthe skin of the patient while the other portions of the guide 2700remain spaced apart from the patient's skin.

As seen in FIG. 31D, the distal edge 2752 of the vertical extensionmember 2724 is arcuate and a proximal edge 2754 of the verticalextension member 2724 includes a semi-circular path about halfwaybetween the base platform 2722 and the guide rails 2726. As seen inFIGS. 31E-31F, the base platform 2722 includes a pair of channels 2756extending parallel to each other and extending longitudinally. Thesechannels 2756 may coaxially align with snap features 2758 in the uppermount coupling mechanism 2714 of the lower mount 2704 to facilitate theupper mount 2702 being coupled with the lower mount 2704. Once thechannels 2756 and the snap features 2758 are aligned, the upper andlower mounts 2702, 2704 may be snapped together such that the snapfeature 2758 extends through the channels 2756 to securely couple themounts together. While the figures show channels 2756 and snap features2758, other mechanisms are possible to couple the upper and lower mounts2702, 2704. For example, the base platform 2722 and the upper mountcoupling mechanism 2714 may each include through holes that coaxiallyalign. And, screws or nuts/bolts may be used to secure the mounts 2702,2704 together.

As seen in FIGS. 31B-31C and 31E, the bottom surface 2762 of the baseplatform 2722 includes a rectangular rail or protrusion 2764 extendinglongitudinally. The top surface of the base platform 2722 includes alongitudinally extending groove, which may be used to align the guidemember 2708 with the sagittal plane of the ultrasound probe. As seen inFIG. 31E, the channels 2756 extend through the rail 2764. As will bedescribed subsequently, the rail 2764 may engage with a platform 2766 ofthe upper mount coupling mechanism 2714 of the lower mount 2704 so as toalign the upper and lower mounts 2702, 2704 upon coupling together.

Reference is made to FIGS. 32A-32C, which depict, respectively, a frontisometric view, a front view, and a back view of the displacement member2710. As described previously, the translating or displacement member2710 may be coupled with the guide rails 2726 of the guide member 2708so as to be displaceable or slidable between the proximal end 2718 ofthe guide member 2708 to the distal end 2716. Thus, when the accessneedle 2712 is coupled with the displacement member 2710, the accessneedle 2712 is also displaceable between the proximal end 2718 of theguide member 2708 to the distal end 2716.

As seen in the figures, the displacement member 2710 includes a centralvertically extending member 2760 having five needle receiving ports 2768formed therein. Each needle receiving port 2768 includes an opening 2770extending from a distal end 2772 to a proximal end 2774 of thedisplacement member 2710. Each of the openings 2770 of the needlereceiving ports 2768 are generally vertically aligned with each otherand each includes a trajectory axis 2776 defining a trajectory of theaccess needle 2712 when positioned within the opening 2770. Thetrajectory axis 2776 is generally parallel to the longitudinal axis 2720of the guide member 2708 when the displacement member 2710 is coupledwith the guide member 2708. The trajectory axis is also generallyparallel with a longitudinal axis of the probe when the biopsy guide2700 is coupled with the probe. Thus, the trajectory axis 2776 of theaccess needle 2712 may be generally fixed or constant, in a generallyparallel orientation to the previously described axes, as thedisplacement member 2710 displaces distal-proximal relative to the guidemember 2708.

A particular needle receiving port 2768 may be chosen based on a desireddistance from the probe. Thus, if a physician desires that the accessneedle 2712 should be positioned nearer the probe, a particular needlereceiving port 2768 may be chosen that is at the bottom of thedisplacement member 2710. In certain embodiments, the openings 2770 ofthe needle receiving ports 2768 may be vertically spaced apart about 5mm. In certain embodiments, the openings 2770 of the needle receivingports 2768 may be vertically spaced apart about 3 mm. In certainembodiments, the openings 2770 of the needle receiving ports 2768 may bevertically spaced apart about 4 mm. In certain embodiments, the openings2770 of the needle receiving ports 2768 may be vertically spaced apartat any interval between about 2 mm to about 6 mm, among other distances.

While the vertically extending member 2760 includes five needlereceiving ports 2768, it is foreseen that more or less ports may beincluded in the displacement member 2710 without limitation.

The displacement member 2710 further includes a coupling mechanism 2778to displaceably couple the displacement member 2710 and the guide rails2726. The coupling mechanism 2778 includes a pair of lower tab members2780 extending laterally out and away from the vertically extendingmember 2760. When coupled with the guide rails 2726, the lower tabmembers 2780 may abut or be positioned adjacent the bottom surface 2730of the rectangular member 2728. The tab members 2780 include a planartop surface 2782 that may provide sliding contact with the bottomsurface 2730 of the rectangular member 2728. The planar contact betweenthe surfaces may contribute to stability of the displacement member 2710relative to the guide rails 2726 by reducing vertical tilt of thedisplacement member 2710.

The coupling mechanism 2778 further include an upper member 2784positioned above the lower tab members 2780. A bottom surface 2786 ofthe upper members 2784 may abut or be positioned adjacent the topsurface 2744 of the rectangular member 2728 when the displacement member2710 is coupled with the guide rails 2726. The bottom surface 2786 ofthe upper members 2784 is planar and, thus, the planar contact betweenthe surfaces may contribute to stability of the displacement member 2710relative to the guide rails 2726 by reducing vertical tilt of thedisplacement member 2710. The upper members 2784 and the lower tabmembers 2780 operate to sandwich the rectangular members 2728 of theguide rails 2726 when the displacement member 2710 is coupled with theguide member 2708.

The coupling mechanism 2778 further includes a lateral brace mechanism2788 at lateral ends of the upper members 2784. The lateral bracemechanism 2788 includes an upside-down U-shaped member 2790 having threeinner surfaces 2792 that define a longitudinal extending channel 2794therein. The channel 2794 may receive the side members 2732 therein whenthe displacement member 2710 couples with the guide rails 2726. In thisway, the lateral brace mechanism 2788 may contribute to stability of thedisplacement member 2710 relative to the guide rails 2726 by reducinglateral tilt of the displacement member 2710. It is foreseen that thedisplacement member 2710 may not include the lateral brace mechanism2792 and may instead only include the upper member 2784 and the lowertab members 2780. Alternatively, it is foreseen that the displacementmember 2710 may not include the upper member 2784 and the lower tabmembers 2780, but may only include the lateral brace mechanism 2792.Additionally and alternatively, other mechanisms are possible tofacilitate the displacement member 2710 displacing between the proximaland distal ends 2718, 2716 of the guide member 2708. For example, theguide member 2708 could include longitudinally extending rods (notshown) and the displacement member 2710 may include a sleeve thatengages and is guided by the rods. In such an embodiment, the rods maybe adapted to slide within the openings 2770 of the needle receivingports 2768 with or without modification to the displacement member 2708.

Still referring to FIGS. 32A-32C, flanges 2796 extend laterally from theupside-down U-shaped members 2790, which may act as grasping points forthe physician. The flanges 2796 extend inwardly and are coplanar with aback wall member 2798 that spans between the upside-down U-shapedmembers 2790, the vertically extending member 2760, and the uppermembers 2784. The back wall member 2798 may function to provide rigiditybetween the various components of the displacement member 2710. As seenin FIG. 32C, a proximal side 2800 of the needle receiving ports 2768includes keyed features to lockingly engage the access needle 2712 suchthat it does not rotate once it is coupled with the port 2768.

Reference is made to FIGS. 33A and 33B, which depict, respectively, afront isometric view and a front view of the lower mount 2704 of thebiopsy guide 2700. As previously described, the upper mount couplingmechanism 2714 includes the snap features 2758 to couple with thechannel 2756 in the base platform 2722. Each of the snap features 2758may be vertical flanges 2802 with a lip 2804 at its verticaltermination. As the inner surfaces defining the channels 2756 contactthe vertical flanges 2802, the inner surfaces compress the lips 2804together relative to each other until the flanges 2802 “snap” or expandoutwardly relative to each other such that the lips 2804 are on a topsurface of the base platform 2722. The vertical flanges 2802 extend fromthe platform 2766 of the upper mount coupling mechanism 2714. Theplatform 2766 is coupled with the probe coupling mechanism 2706, which,as seen in the figures, may be a snap-grip or snap-clip type of hose ortube clamp. The mechanism 2706 may include a first and a second armmember 2804, 2806 extending from opposite sides 2808 of the platform2766. The arm members 2804, 2806 are flexible and designed to wraparound a portion of the probe fitted within the opening formed by thefirst and second arms 2804, 2806. The first arm member 2804 includes afirst clamping structure 2810 including an upper row of teeth 2812 and alower smooth sliding surface 2814. The second arm member 2806 includes asecond clamping structure 2816 including an upper smooth sliding surface2818 and a lower row of teeth 2820. The first and second clampingstructures 2810, 2816 work together to provide a clamping or grippingfunction to securely support the transrectal probe to the lower mount2704 and, thus, the upper mount 2702.

In operation, a transrectal probe is positioned within the openingbetween the first and second clamping structures 2810, 2816. Thephysician may determine a desired position on the probe based on thepatient's anatomy, the particular transrectal probe, or the particularprocedure to be performed, among other possible criteria. Once aposition for the lower mount 2704 is chosen, the physician may cause thefirst and second arm members 2804, 2806 to be contracted relative toeach other by pushing on the outer ends 2822 of the clamping structures2810, 2816, respectively. As the clamping structures 2810, 2816 convergerelative to each other, the lower row of teeth 2820 on the secondclamping structure 2806 is received within an opening 2824 formedbetween the upper row of teeth 2812 and the lower smooth surface 2814.The upper row of teeth 2812 are caused to engage with the lower row ofteeth 2820. Additionally, the upper smooth surface 2818 is caused toslide on an inner smooth surface 2826 of the first arm member. And, thelower smooth sliding surface 2814 is caused to slide on a lowest smoothsurface 2828 on the second clamping structure 2816. The teeth of theupper and lower row 2812, 2820 are arranged in a saw tooth like mannersuch that when they are increasingly engaged with each other the teethgrip each other and resist moving in the opposite direction. Onceengaged, the teeth may be disengaged by pulling on a tab 2830 on abottom portion of the first clamping structure 2810. Pulling on the tab2830 allows the teeth 2812, 2820 to disengage with each other and theflexible nature of the first and second arms 2804, 2806 are caused tospring back into the shape shown in FIG. 33B. As seen in FIGS. 33B-33B,an inner surface 2834 of the first and second arms 2804, 2806 includes agasket 2832 that may be flexible and deformable to provide for agripping surface between the probe and the lower mount 2704.

Reference is made to FIG. 34 , which depicts a front isometric view ofan access needle 2712. As seen in the figure, the needle 2712 includes adistal end 2836 and a proximal end 2838 opposite the distal end 2836. Atthe distal end 2836 is the bevel 2840 extending distally from a shaft2842. Within the shaft 2842 is a lumen 2844 for communication of fluidsor, in the case of the access needle 2712, a shaft of a smaller gagebiopsy needle. The proximal end 2838 of the needle 2712 includes a hub2846 with ridges 2848 extending longitudinally around a circumference ofthe hub 2846. The ridges 2848 may engage with corresponding andnegatively shaped features on the proximal side 2800 of the needlereceiving ports 2768.

The following discussion will focus on use of the biopsy guide 2700 andwill refer to FIGS. 35A-35D, which depict, respectively: a frontisometric view of the lower mount 2704; a front isometric view of thelower mount 2704 coupled with the upper mount 2702; a front isometricview of the lower mount 2704 coupled with the upper mount 2702 and thedisplacement member 2710 positioned at a proximal end of the guidemember 2708; and, a front isometric view of the lower mount 2704 coupledwith the upper mount 2702 and the displacement member 2710 positioned ata proximal end of the guide member 2708 with the access needle 2712positioned within one of the needle receiving ports 2768.

As seen in FIG. 35A, the lower mount 2704 is positioned with the firstand second clamping structures 2810, 2816 of the first and second armmembers 2804, 2806 uncoupled such that a transrectal probe maypositioned between the arm members 2804, 2806. While it is not depictedin the figures, the first and second clamping structures 2810, 2816 maybe engaged with each other or coupled as described previously to graspthe probe between the arm members 2804, 2806 and against the gasket2832.

As seen in FIG. 35B, the upper mount 2702 may be coupled with the lowermount 2704. More particularly, the vertical flanges 2802 on the platform2766 of the upper mount coupling mechanism 2714 may be engaged with orsnapped together with the channels 2756 on the base platform 2722 of theguide member 2708.

As seen in FIG. 35C, the displacement member 2710 may be engaged withthe guide member 2708. More particularly, the distal end 2772 of thedisplacement member 2710 is longitudinally aligned with the proximal end2718 of the guide member 2708 such that the proximal ends of the guiderails 2726 are positioned to extend into the corresponding features ofthe displacement member 2710. That is, the rectangular member 2728 isaligned with the opening between the upper members 2784 and the lowertab members 2780, and the vertically extending side members 2732 arealigned with the channels 2794 between the inner surfaces 2792 of theupside-down U-shaped member 2790 of the displacement member 2710. Oncealigned, the displacement member 2710 is displaced, moved, or translatedinto engagement with the guide member 2708, as seen in FIG. 35C, whichdepicts the displacement member 2710 in a proximal-most position.

As seen in FIG. 35D, the access needle 2712 is coupled with thedisplacement member 2710. More particularly, the bevel 2840 and shaft2842 of the access needle 2712 are extended through the proximal side2800 of a particular opening 2770 of a needle receiving port 2768 untilthe hub 2846 of the access needle 2712 engages with the proximal side2800 of the port 2768. The ridges 2848 of the access needle 2712 mayengaged with corresponding features within the opening 2770 of the port2768 such that the access needle 2712 remains coupled with thedisplacement member 2710. The access needle 2712 may be restrained fromrotating by the ridges 2848. In certain embodiments, the access needle2712 may be secured to the displacement member 2710 by, for example, athreaded features on the hub 2846 and openings 2770 of the ports 2768such that the needle 2712 and the displacement member 2710 may bethreadably engaged and disengaged with each other.

In the orientation shown in FIG. 35D, the displacement member 2710 andthe access needle 2712 are in a proximal-most position or condition. Asseen in the figure, in this particular embodiment, the bevel 2840 of theaccess needle 2712 lies about flush with the planar distal face 2740 ofthe distal member 2734. In other embodiments or with a different sizedneedle 2712, the bevel 2840 of the access needle 2712 may extend beyondthe distal face 2740 of the distal member 2734 when the displacementmember 2710 is in the proximal-most position, or the bevel 2840 of theaccess needle 2712 may be positioned proximal of the distal face 2740 ofthe distal member 2734 when the displacement member 2710 is in theproximal-most position.

In certain embodiments where the bevel 2840 of the access needle 2712does not extend past the distal face 2740 of the distal member 2734, thephysician may use the distal member 2734 to manipulate the perineal skinand subcutaneous tissue of the patient while having the displacementmember 2710 coupled to the guide member 2708, but while not having thebevel 2840 of the access needle 2712 contact the patient's skin.

While FIG. 35D depicts the access needle 2712 coupling with thedisplacement member 2710 when the displacement member 2710 is in theproximal-most position, the access needle 2712 may be engaged with thedisplacement member 2710 when the displacement member is at thedistal-most position or at any position between the distal-most positionand the proximal-most position. When the access needle 2712 is in theproximal-most position, as shown in FIG. 35D, the physician maymanipulate the probe and the distal member 2734 of the upper mount 2702to manipulate the perineal skin and subcutaneous tissue of the patient.When the trajectory of the access needle 2712 is appropriatelypositioned relative to the patient's perineal skin and subcutaneoustissue, the physician may distally displace the access needle 2712 bypushing on one or more of the back wall member 2798 or flanges 2796 ofthe displacement member 2710, or the hub 2846 of the access needle 2712.In certain embodiments, the displacement member 2710 may be biased orspring-loaded such that the physician may actuate a mechanism thatdistally advances the displacement member 2710 and the access needle2712 without a need for manual advancement by the physician. As theaccess needle 2712 and the displacement member distally advance ordisplace, the displacement member 2712 will lock or be secured into thedistal-most position via the ramps of the stop feature 2746 positionedon the top surface 2744 of the rectangular member 2728. In thedistal-most position, as seen in FIG. 27 , the displacement member 2710is prevented from further distal displacement via the distal member2734. In particular, a front edge or surface 2850 of the distal end 2772of the displacement member 2710 abuts or is adjacent a proximal surface2748 of the distal member 2734 when the displacement member 2710 is inthe distal-most position. In certain embodiments, as seen in FIG. 27 ,the back surface 2748 may abut or be adjacent the front edge or surface2850 of the upper members 2784, the lower tab members 2780 (not seen inFIG. 27 ) and/or part of the upside-down U-shaped member 2790.

As further seen in FIG. 27 , the distal members 2734 extend inwardtowards the needle receiving ports 2768 but may define an opening or gapbetween the rounded inner edges 2736 for the access needle 2712 toextend therethrough.

Once the access needle 2712 is in position in the patient's skin andsubcutaneous tissue, the biopsy procedure may continue, as describedpreviously, with the physician extending a biopsy needle through thelumen 2844 of the access needle 2712 and into the patient's prostate.Once procedure is complete, the physician may remove the access needle2712 from the patient's body by proximally displacing the displacementmember 2710 and the access needle 2712 by pulling or pushing on thedisplacement member 2710 or access needle. Alternatively, the accessneedle 2712 may be disengaged with the displacement member 2710 whilethe displacement member 2710 is in the distal-most position.

The discussion will now focus on additional and alternative embodimentsof the biopsy guide. As seen in FIG. 36 , the displacement member 2710may include the upper members 2784 and the lower tab members 2780 forengaging with and sliding or displacing relative to the rectangularmembers 2728 of the guide rails 2726. The displacement member 2710 ofFIG. 36 , however, does not include an upside-down U-shaped member forengaging with the side members 2732 of the guide rails 2726 and,further, does not include the back wall member 2798 and the flanges2796. Features of both embodiments of the displacement member 2710 maybe combined as needed and without limitation.

The lower mount 2704, as described herein, may take many forms withoutdeparting from the scope of the present disclosure. Other mechanisms tocouple the upper mount 2702 to the probe are possible and contemplatedherein. For example, the upper mount 2702 may couple with or beintegrally formed with a thin sheath or sleeve of latex, polyurethane,or other materials, such as a male condom. The sheath may be fitted overthe probe in a tight fitting manner such that the upper mount 2702 issecured in position relative to the probe.

Additional or alternative embodiments of the lower mount 2704 mayinclude rubber or rubber-type cinch straps that are coupled with orintegral with the upper mount 2702.

The upper mount 2702, as described herein, may take many forms withoutdeparting from the scope of the present disclosure. Other mechanisms toguide the access needle 2712 are possible and contemplated herein. Forexample, the displacement member 2710 supporting the access needle 2712may be coupled to a platform on a coupler side of a four-bar linkage(e.g., parallelogram linkage) where the fixed portion of the linkage maybe coupled with the base platform 2722 of the guide member 2710. Theplatform may be displaceable distal-proximal by urging the platformdistally or proximally, while displacing in an arcuate path. In the caseof a parallelogram linkage, the trajectory of the access needle 2712 mayremain parallel to the longitudinal axes of the probe and guide member2710 while vertically displacing. In this way, such a linkage may beused for distal-proximal displacement as well as vertical displacementor adjustment, as needed for a particular biopsy procedure. This type ofdisplacement member 2710 may be used with the guide member 2708 asdescribed herein with or without modification.

As another example, the displacement member 2710 supporting the accessneedle 2712 may be coupled to a carriage or lead screw nut that isdisplaced relative to the guide member 2708 (and probe) via rotation ofa lead screw. The lead screw may be positioned parallel to thelongitudinal axis of the guide member 2708 and the probe such thatdisplacement of the lead screw nut and, thus, the displacement member2710 and access needle 2712 displace or translate distal-proximal whilemaintaining a trajectory of the access needle 2712 that may be fixed. Abottom side of the lead screw nut may include a feature or protrusionthat extends into a channel formed in the base platform 2722 of theguide member 2708 such that the lead screw nut does not rotate, but,rather, displaces or translates linearly distal-proximal in response torotation of the lead screw. The lead screw may be rotatable by hand via,for example, a handle at the proximal end of the lead screw.

Reference is now made to FIGS. 37A-37F, which depict various views ofanother embodiment of the biopsy guide 3700. As seen in FIG. 37A, whichis a front isometric view of the biopsy guide 3700, the guide 3700 issimilar to previously described embodiments of the guide in that itincludes an upper mount 3702 and a lower mount 3704. The lower mount3704 is adapted to secure the guide 3700 to a transrectal probe andincludes the same features as the previously described embodiment. Theupper mount 3702 may releasably couple with the lower mount 3704. Asseen in FIGS. 37B and 37C, which are, respectively, front and backisometric exploded views of the upper mount 3702, the biopsy guide 3700further includes a guide member 3710 and a displacement, sliding, ortranslating member 3706 that is adapted to couple with an access needle3708.

As seen in FIGS. 37B-37C and 37E-37F, the displacement member 3706includes a vertically extending member 3712 having five needle receivingports 3714 formed within the member 3712. The ports 3714 may receive theaccess needle 3708 within any of the ports 3714, as previouslydescribed, to vary the height of the access needle 3708 relative to theprobe (not shown). The access needle 3708 may couple with the needlereceiving ports 3714 such that they may be displaced together relativeto the guide member 3710.

As seen in the figures, a bottom end 3716 of the vertically extendingmember 3712 is coupled to a distal end 3718 of a rail member 3720 thatmay slidingly engage with the guide member 3710. The rail member 3720includes a flange member 3722 and a web member 3724 arranged in a T-beamshape. That is, the flange member 3722 is wider than the web member3724, which projects upward and substantially perpendicularly from acentral portion of the flange member 3722. From the distal end 3718, therail member 3720 extends proximally to a proximal end 3726. At theproximal end 3726 is an end plate member 3728, which prevents distaldisplacement of the displacement member 3706 past a certain point.

As seen in FIGS. 37C and 37D, the guide member 3710 includes a railreceiving slot or channel 3730 having a proximal opening 3732, a distalopening 3734 (seen in FIG. 37B), and a top opening 3736. The railreceiving slot 3730 is generally a negative shape of the rail member3720 and may receive the rail member 3720 therein and permit the railmember 3720 and, thus, the displacement member 3706 and access needle3708 to displace relative to the guide member 3710. When the rail member3720 is positioned within the rail receiving slot 3730, inner surfaces3738 of the slot 3730 may contact the flange and web members 3722, 3724and restrain the displacement member 3706 from lateral displacement andvertical tilting while allowing distal-proximal displacement ortranslation of the displacement member 3706. Thus, the displacementmember 3706 may be displaced or translated distally and proximally whilemaintaining alignment of a trajectory of the access needle 3708substantially parallel with a longitudinal axis of the probe when thebiopsy guide 3700 is coupled with the probe.

As seen in FIG. 37A, the displacement member 3706 is in a distal-mostposition with the distal end 3718 of the rail member 3720 and a distalend 3740 of the vertically extending member 3712 being about coplanarwith a distal face 3742 of a distal member 3744 of the guide railmembers 3746, which may be similar to as previously described inrelation to previous embodiments. In the distal-most position, the railmember 3720 extends past the distal opening 3734 of the rail receivingslot 3730, and the end plate member 3728 of the rail member 3720 abutsor is adjacent the proximal opening 3732 of the rail receiving slot3730. To proximally displace the displacement member 3706 from thedistal-most position, the physician may pull or push on the end platemember 3728, the vertically extending member 3712, or the access needle3708.

It is noted that the guide rail members 3746 and, more particularly, thedistal members 3744 may be used by the physician to manipulate theperineal skin and subcutaneous tissue of the patient, as describedpreviously. And while the embodiment of the biopsy guide 3700 in FIGS.37A-37F describe a rail and slot type of arrangement between thedisplacement member 3706 and the guide member 3710, other mechanisms arepossible to displace the displacement member 3706 relative to the guidemember 3710. Additionally or alternatively, features and elements fromother embodiments of the biopsy guide may be incorporated into thepresent embodiment without limitation. Similarly, features and elementsfrom the present embodiment of the biopsy guide may be incorporated intoany of the other embodiments of the biopsy guide without limitation.

As seen in FIG. 37G, which is a side view of another embodiment of thedisplacement member 3706 with the access needle 3708 partiallypositioned within the top needle receiving port 3714 of the verticallyextending member 3712, the rail member 3720 may be replaced by a leadscrew 3748 and the bottom end 3716 of the vertically extending member3712 may include a lead screw nut 3750 that rotationally engages withthe lead screw 3748 to cause the displacement member 3706 and the accessneedle 3708 to displace or linearly translate relative to the probe andthe guide member 3710 (not shown). The lead screw 3748 may berotationally coupled with bearings 3752 at opposite ends which allow thelead screw 3748 to rotate thereon. The lead screw nut 3750 may beprevented from rotating by a guide rail 3754 that extends between thebearings 3752 and also extends through a passageway in the lead screwnut 3750. In this way, as the lead screw 3748 rotates, the lead screwnut 3750, as well as the vertically extending member 3712 and the accessneedle 3708, are caused to displace or translate distal-proximal becausethe lead screw nut 3750 is prevented from rotating by the guide rail3754. The lead screw 3748 may include a handle 3756 for rotating thelead screw 3748. The displacement member 3706 shown in FIG. 37G may becoupled with the guide member 3710 shown in the previous figures suchthat the lead screw 3748 is generally parallel with the longitudinalaxis of the guide member 3710 and the probe. The displacement member3706 may, for example, couple with the base platform of the guide member3710 at the bearings 3752, or at other parts of the member 3706.

As seen in FIGS. 37H-37I, which are, respectively, an isometric frontview and a side view of another embodiment of the biopsy guide 3900, itincludes a probe coupling mechanism 3902 in the form of collars that maybe adjustably secured to the probe 3904. Four arm members 3906 arepivotally coupled at bottom ends 3908 to the probe coupling mechanism3902 and pivotally coupled at top ends 3910 to a platform member 3912.The arm members 3906 may be of equal length such that the platformmember 3912 is capable of displacing distal-proximal while maintaining aparallel orientation relative to the probe 3904. More particularly, asseen in FIG. 37I, the platform member 3912 may include a longitudinalaxis that is generally parallel to a longitudinal axis of the probe 3904in all distal-proximal orientations of the platform member 3912 relativeto the probe 3904. The platform member 3912 may include a longitudinallyextending channel 3914 for receiving and guiding a displacement member3916 having a needle receiving port 3918. The displacement member 3916may include a flanged lower body portion 3920 that matches a shape ofthe channel 3914 such that the displacement member 3916 may slide withinthe channel 3914 or displace relative to the platform member 3912 whilemaintaining an orientation of a needle positioned within the needlereceiving port 3918 that is generally parallel to the longitudinal axisof the probe 3904.

As seen in FIG. 37I, the biopsy guide 3900 may function as a four barparallel or parallelogram linkage during displacement of the platformmember 3912. In particular, FIG. 37I shows three positions of theplatform member 3912 as it displaces. A first position 3922 shows theplatform member 3912 at a highest position relative to the probe 3904where the arm members 3906 are vertically extended to their maximum. Asecond position 3924 shows the platform member 3912 as it distallydisplaces while rotating clockwise and lowering the platform member 3912relative to the probe. A third position 3926 shows the platform member3912 as it further distally displaces while rotating clockwise andlowering the platform member 3912 relative to the probe. As seen in allpositions 3922, 3924, 3926, a longitudinal axis of the platform member3912 may remain generally parallel with a longitudinal axis of the probe3904.

Reference is now made to FIG. 37J, which is a front isometric view ofanother embodiment of an upper mount 4000. As seen in the figure, theupper mount 4000 includes a guide member 4002 that is similar topreviously described embodiments in that it includes a pair of guiderails 4004 that extend longitudinally and are spaced apart from eachother. This embodiment of the upper mount 4000, however, does notinclude a displacement member. Rather, the guide mount 4002 of the uppermount 4000 of FIG. 37J includes a vertically oriented member 4008including needle receiving ports 4006 that are also vertically aligned.The member 4008 may not be displaceable relative to the guide member4002 in this particular embodiment.

That is, the needle receiving ports 4006 may align a trajectory of anaccess needle in any of the ports 4006 such that a trajectory of theaccess needle may be generally parallel to a longitudinal axis of theprobe. The needle receiving ports 4006 may be integrally formed with theguide member 4002. Or, the vertical member 4008 including the needlereceiving ports 4006 may be releasably coupled to the guide member. In areleasable arrangement, the vertical member 4008 may be coupled with theguide member via any coupling mechanism described herein or known in theart. As seen in the figure, the needle receiving ports 4006 arecylindrical and extend generally from a proximal end 4010 to a distalend 4012 of the guide member 4002. The distal tip 4014 of the needlereceiving ports 4006 may be about coplanar with a distal face 4016 ofthe distal members 4018 of the guide rails 4004.

Reference is made to FIGS. 37K-37L, which are, respectively, front andside views of another embodiment of a biopsy guide 4100. As seen in thefigures, the biopsy guide 4100 includes displacement member 4102including a vertically oriented body 4104 having five vertically alignedneedle receiving ports 4106 for receiving, supporting, and orienting anaccess needle. At a bottom end 4108 of the vertical body 4104 is a probecoupling mechanism 4110 including a collar 4112 having a guide rail orprotrusion 4114 extending from an inner surface 4116 of the collar 4112.The guide rail 4114 extends longitudinally in the collar 4112 and may bereceived by a correspondingly shaped channel or slot 4120 in atransrectal probe 4118. In this way, the displacement member 4102 mayslide, displace, or translate relative to the probe 4118 while beingrestrained from certain movements by the interaction between the guiderail 4114 and the channel 4120. As such, the access needle supported bythe needle receiving port 4106 may displace or translate distal-proximalrelative to the probe 4118 while maintaining a trajectory that isgenerally parallel with a longitudinal axis of the probe 4118.

The inner surface 4116 may include roller bearings or similar structuresto permit the collar 4112 to roll, translate, or displace relative tothe probe 4118. While the channel 4120 is described as being formed inthe probe 4118, the channel 4120 may be formed in a separate member thatis coupled to the probe 4118. In this case, a specialized probe having achannel may not be needed; rather, any off-the-shelf ultrasound probemay be used with the separate member having the channel 4120 to utilizethe biopsy guide 4100 of the present embodiment.

Reference is made to FIGS. 37M-37U, which depict various views ofalternative embodiments of the lower mount. To begin, reference is madeto FIGS. 37M-37Q. FIG. 37M is a front isometric view of a biopsy guide4200. FIG. 37N is a front view of the biopsy guide 4200. FIG. 37O is afront isometric view of a cinch strap 4202. FIG. 37P is a frontisometric view of a V-block insert 4204. FIG. 37Q is a front view of thebiopsy guide 4200 of FIG. 37M with an insert 4204 of FIG. 37P.

As seen in FIG. 37M, the biopsy guide 4200 includes an upper mount 4206and a lower mount 4208. The upper mount 4206 may include a base platform4210 and a pair of guide rails 4212 extending longitudinally from thebase platform 4210. The guide rails 4212 may guide a displacement member(not shown), which may support an access needle (not shown), asdescribed in previous embodiments. The lower mount 4208 may include acinch strap 4202, as shown in FIG. 37 ), which may include a flange 4214at one end 4216 and a series of transversely extending ridges 4218. Thecinch strap 4202 may be fitted or positioned within a slot 4220 in thebase platform 4210 such that the flange 4214 abuts the surfaces of theslot 4220 and is prevented from extending through the slot 4220. Thecinch strap 4202 may be fitted around the transrectal probe 4222 andpositioned within a locking opening 4224 opposite the slot 4220 in thebase platform 4210. The cinch strap 4202, which may be rubber orotherwise made of a flexible material, may be pulled tightly at the freeend 4226 such that the ridges 4218 are progressively locked by thelocking opening 4224. Once appropriately tightened, the upper mount 4206is now secured to the probe 4222.

As seen in FIGS. 37P-37Q, the lower mount 4208 of the biopsy guide 4200may include a V-block insert 4204 positioned between the probe 4222 andthe cinch strap 4202. The V-block insert 4204 may include a pair ofslots 4228 on opposite sides of the insert 4204 that may be sized toreceive the cinch strap 4202 therethrough to secure the V-block insert4204 into position relative to the cinch strap 4202. The V-block insert4204 ensures at least three points of contact between the probe and thebiopsy guide 4200: one point of contact between the probe 4222 and anunderside of the base platform 4210; and, two points of contact betweenthe probe 4222 and the V-block insert 4204.

Reference is made to FIGS. 37R-37S, which depict, respectively, a frontisometric view and a front view of another embodiment of a biopsy guide4300. Similar to the previously described embodiments, the biopsy guide4300 includes an upper mount 4302 and a lower mount 4304. The uppermount 4302 may include a base platform 4306 and a pair of guide rails4308 extending longitudinally and spaced apart from each other. Theguide rails 4308 may guide a displacement member (not shown), which maysupport an access needle (not shown), as described in previousembodiments. The lower mount 4304 may include a curvilinear shaped innersurface 4310 opposite the base platform 4306 and pair of opposing arms4312 extending downward. The arms 4312 may converge on a bottom side4314 of the lower mount 4304. A V-block insert 4316 may be positioned anopening 4318 of the lower mount 4304. The opening 4318 may be sized andshaped to receive the transrectal probe 4322 therein. The V-block insert4316 may be vertically adjustable within the opening 4318 via athumb-screw 4320. When actuated or rotated, the thumb-screw 4320 maypush the V-block insert 4316 vertically to exert a force on the probe4322, which, in turn, exerts a force on the inner surface 4310 of thebase platform 4306 of the lower mount 4304.

Reference is made to FIGS. 37T-37U, which depict, respectively, a frontisometric view and a front view of another embodiment of a biopsy guide4400. As seen in the figures, the device 4400 includes an upper mount4402 and a lower mount 4404. The upper mount 4402 may include a baseplatform 4406 and a pair of guide rails 4408 extending longitudinallyand spaced apart from each other. The guide rails 4408 may guide adisplacement member (not shown), which may support an access needle (notshown), as described in previous embodiments. The lower mount 4404couples the upper mount 4402 to the probe 4410 and may include a strap4412 that is affixed at one side 4414 via a pair of fasteners (e.g.,screws, bolts) 4416. The strap 4412 may wrap around the probe 4410 andbe secured in place via a worm gear mount 4418. The worm gear mount 4418may include a thumb-knob 4420 that is rotatable and extending to athreaded feature (e.g., ACME threads) 4422 that threadably engage withslots 4424 on the second end 4426 of the strap 4412. As the thumb-knob4420 is tightened, the thread feature 4422 advances on the slots 4424and pulls the strap 4412 tighter on the probe 4410 (similar to a hoseclamp). This embodiment may include a V-block insert (not shown). Asseen in the figures, an underside 4426 of the base platform 4406 may becurvilinear to match the shape of the probe 4410. These features amongfeatures from other embodiments may be combined as needed to modify anyof the features of any of the biopsy guides described herein.

Reference is made to FIGS. 37V-37X, which depict additional andalternative embodiments of a lower mount 4502 of a biopsy guide 4500. Asseen in FIG. 37V, which is a front view of a lower mount 4502, the uppermount 4504 may be similar to previously describe embodiments in that itincludes a base platform 4506 and a pair of guide rails 4508. The lowermount may include a pair of semi-circular arm members, clamps, orcollars 4510 that are pivotally coupled together at a joint 4512 (e.g.,pin). The pair of semi-circular arm members 4510 may open and closeabout the joint 4512 in a clam-shell type manner. Opposite the joint4512, the arm members 4510 are adjustably secured together via athumb-screw 4514 that extends between a pair of flanges 4516. Thus,turning the thumb-screw 4514 in a first direction may cause the pair ofarm members 4510 to constrict against a probe (not shown) positionedwithin the opening 4518 between the arm members 4510. And, turning thethumb-screw 4514 in a second direction may cause the pair of arm members4510 to loosen against the probe positioned within the opening 4518.

FIG. 37W depicts a front isometric view of the lower mount 4504including a flexible spring band or biasing collar 4520 extendingcircumferentially and terminating in a pair of flanges or tabs 4522 thatmay be compressed together, relative to each other, to selectivelyenlarge the opening 4518. The probe (not shown) may be positioned withinthe opening 4518 and the spring band 4520 may compress against the probeand cause a constant force to be exerted on the probe, allowing it to beused on probes of multiple diameters. The flat spring band 4520 may bereplaced by a wire spring band (i.e., dumbbell clamp) without departingfrom the scope of the disclosure.

FIG. 37X depicts a front view of a lower mount 4504 having a pair ofsemi-circular arm members, clamps, or collars 4510 that are pivotallycoupled together at a joint 4512 (e.g., pin). The pair of semi-circulararm members 4510 may open and close about the joint 4512 in a clam-shelltype manner. Opposite the joint 4512, the arm members 4510 areadjustably secured together via a snap-clip, ratchet, or clamp assembly4524 including a lever arm handle 4526 a wire arm or loop 4528. Thelever arm handle 4526 is attached to one free end 4534 of the armmembers 4510 and the wire arm 4528 is attached to the lever arm handle4526. The other free end 4530 of the other arm member 4510 includes alip 4532 such that the wire arm 4528 may be fitted around the lip 4532with the lever arm handle 4526 in an opened position. Once the wire arm4528 is positioned within the lip 4532, the lever arm handle 4526 may bepivoted towards the arm member 4510, which pulls the free ends 4534,4530 together to secure the arm members 4510 against the probe (notshown). To remove the probe from the lower mount 4504, the lever armhandle 4526 may be pivoted outward away from the arm member 4510 of thefree end 4534 and the arm members 4510 will expand relative to eachother and release the probe.

As with many of the embodiments of the biopsy guide described herein,there may be a particular type of mechanical arrangement between theguide member and the displacement member that at least facilitates thedisplacement of the access needle along at least a portion of the lengthof the guide member. As discussed in relation to each of theembodiments, the mechanical arrangement may include at least one of asliding arrangement, a lead screw, or a parallel bar linkage. And, asdescribed with reference to the various embodiments of the biopsy guide,the guide member may operably couple with the transrectal probe via atleast one of a sheath arrangement, a ratchet arrangement, a biasedcollar arrangement, a flexible strap arrangement, a clampingarrangement, or a clamshell collar arrangement.

Reference is now made to FIGS. 38A-38D, which depict, respectively, atransverse plane or slice image of a prostate 3800 and a urethra 3804, asagittal plane or slice image of a prostate 3800 and a urethra 3804, atransverse plane or slice image of a prostate 3800 and a urethra 3804with a marking device 3824 positioned within the urethra 3804, and asagittal plane or slice image of a prostate 3800 and a urethra 3804 witha marking device 3824 positioned within the urethra 3804. As mentionedpreviously, during a prostate biopsy procedure it may important for thephysician to identify the path of the urethra so that he or she canavoid puncturing the urethra with the access needle and the biopsyneedle. The biopsy guides described herein may be used with varioussystems to locate the urethra via the transrectal probe in sagittal andaxial planes.

As described previously, the probe or transducer provides imaging inaxial and sagittal planes so as to provide real-time images of theprostate. As seen in FIG. 38A, which is a transverse plane showing theprostate 3800 and the probe 3802, the urethra 3804 is shown, as well asa path 3806 of the urethra 3804, as would be seen in a sagittal plane.As seen in FIG. 38B, which is a sagittal plane showing the prostate 3800and the probe 3802, the urethra 3804 is shown extending over theprostate 3800 and connecting with the bladder 3808.

When the prostate is viewed, as seen in FIGS. 38A and 38B, the physicianmay then position the access needle 2712 in an access site 3810 in thesubcutaneous tissue 3812 of the perineum 3814, where the access site3810 is at a midpoint between a lateral edge of the prostate 3816 andthe urethral path 3806 along a first axis and a midpoint between ananterior capsule 3818 and a posterior capsule 3820 along a second axis.The physician may guide the probe 3802 and the biopsy guide (not shown)along a sagittal plane to the target using the real-time image from theprobe 3802, and the physician may obtain one or more specimens 3822 ofthe prostate 3800 through the access needle 2712 being guided by thebiopsy guide.

Identifying the urethra may be accomplished via a number of methods.First, as seen in FIGS. 38C-38D, a marking device 3824 such as, forexample, a balloon catheter can be inserted into the urethra 3804 andused by the physician to locate the urethra 3804. As seen in FIG.38C-38D, the marking device 3824 may include a catheter 3826 and aballoon 3828. The balloon 3828 may be expanded in the bladder 3808 andthe catheter 3826 may extend through the urethra 3804 and out of thepatient's body. The balloon 3828 and/or catheter 3826 may be visible incertain planes during the biopsy procedure and may aid in identifyingthe urethra 3804.

Additionally or alternatively, the marking device 3824 may includemarkers 3830 such as physical or chemical markers that are visible in anultrasound environment (e.g., pellets of polylactic and polyglycolicacids containing carbon dioxide, polyglycolic acid pads) along thelength of the catheter 3826 so that the physician can view the path ofthe urethra 3804 as viewed in transverse or sagittal planes. Thus, thephysician may be able to position a trajectory of the access needle 2712to be adjacent and not intersecting with the path of the urethra asindicated by the markers 3830 on the catheter 3826. The markers 3830 maybe positioned on the catheter at certain intervals so as to provide away to estimate the size or volume of the prostate 3800. Additionally oralternatively, the catheter 3826 may include a contrast medium (e.g.,dye) for visualization purposes and may otherwise function similarly tomarkers 3830 positioned on the catheter 3826.

The biopsy guides and devices described herein may additionally includemarkers or sensors positioned on the biopsy guide or access needle suchthat movement of the guide or needle, or any device/material placedthrough the access needle, may be visualized via the markers/sensors byultrasound equipment (e.g., probe) or other equipment using differentimaging modalities (e.g., MRI, CT). In this way, for example, a markerpositioned at a distal end of the access needle may provide visualguidance as to the location of the tip of the access needle relative tothe boundaries of the prostate.

Although various representative implementations have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of the inventive subject matter setforth in the specification. All directional references (e.g., distal,proximal, front, back, side, top, bottom, fore, aft, right, left, etc.)are only used for identification purposes to aid the reader'sunderstanding of the implementations, and do not create limitations,particularly as to the position, orientation, or use of the embodimentsdescribed herein unless specifically set forth in the claims. Joinderreferences (e.g., attached, coupled, connected, and the like) are to beconstrued broadly and may include intermediate members between aconnection of elements and relative movement between elements. As such,joinder references do not necessarily infer that two elements aredirectly connected and in fixed relation to each other.

It is believed that the present disclosure and many of its attendantadvantages will be understood by the foregoing description, and it willbe apparent that various changes may be made in the form, constructionand arrangement of the components without departing from the disclosedsubject matter or without sacrificing all of its material advantages.The form described is merely explanatory, and it is the intention of thefollowing claims to encompass and include such changes.

While the present disclosure has been described with reference tovarious embodiments, it will be understood that these embodiments areillustrative and that the scope of the disclosure is not limited tothem. Many variations, modifications, additions, and improvements arepossible. More generally, embodiments in accordance with the presentdisclosure have been described in the context of particularimplementations. Functionality may be separated or combined in blocksdifferently in various embodiments of the disclosure or described withdifferent terminology. These and other variations, modifications,additions, and improvements may fall within the scope of the disclosureas defined in the claims that follow.

What is claimed is:
 1. A method of performing a transperineal biopsyprocedure on a prostate of a patient using a transrectal ultrasoundprobe configured to provide imaging in at least a sagittal imagingplane, the patient comprising a perineal access site leading to theprostate, the method comprising: imaging the prostate of the patientwith the transrectal ultrasound probe, wherein a transperineal biopsyguide is coupled to the transrectal ultrasound probe, the transperinealbiopsy guide comprising a mount including an adjustable fastener coupledto the transrectal ultrasound probe, a guide member coupled to the mountand including a rail receiving channel extending a first length betweena proximal end and a distal end, and a displacement member including arail member extending a second length between a proximal end and adistal end, and a vertically extending member coupled to the distal endof the rail member, the vertically extending member including aplurality of needle receiving ports; sliding the rail member within therail receiving channel so as to position the vertically extending memberof the displacement member adjacent the perineal access site of thepatient; inserting an access needle through one of the plurality ofneedle receiving ports and into the perineal access site of the patient,the access needle positioned within the sagittal imaging plane; andinserting a needle through the access needle and into a first locationof the prostate of the patient.
 2. The method of claim 1, furthercomprising: contacting a distal end of a pair of guide rails of theguide member with the perineal access site of the patient, the pair ofguide rails being spaced apart from each other and positioned onopposite sides of the rail receiving channel.
 3. The method of claim 1,further comprising injecting a substance into the patient via theneedle.
 4. The method of claim 1, further comprising taking a firstbiopsy of the first location of the prostate of the patient via theneedle.
 5. The method of claim 4, further comprising taking a secondbiopsy of a second location of the prostate of the patient via theneedle, the second location being different than the first location. 6.The method of claim 5, wherein the access needle remains positionedwithin the perineal access site of the patient for the first biopsy andthe second biopsy.
 7. The method of claim 1, wherein the rail receivingchannel is positioned generally parallel with a longitudinal axis of thetransrectal ultrasound probe.
 8. The method of claim 1, wherein thedisplacement member includes an end plate coupled to the proximal end ofthe rail member, the end plate configured to contact a proximal end ofthe guide member in order to limit displacement of the displacementmember relative to the guide member.
 9. The method of claim 1, whereinthe plurality of needle receiving ports portion comprises at least fiveneedle receiving ports oriented vertically relative to the rail member.10. The method of claim 1, further comprising engaging a portion of theguide member to the perineal access site of the patient prior toinserting the access needle into the perineal access site of thepatient.
 11. A method of performing a transperineal biopsy procedure ona prostate of a patient using a transrectal ultrasound probe configuredto provide imaging in at least a sagittal imaging plane, the patientcomprising a perineal access site leading to the prostate, the methodcomprising: imaging the prostate of the patient with the transrectalultrasound probe, wherein a transperineal biopsy guide is coupled to thetransrectal ultrasound probe, the transperineal biopsy guide comprisinga mount including an adjustable fastener coupled to the transrectalultrasound probe, a guide member coupled to the mount and including arail receiving channel extending a first length between a proximal endand a distal end, and a displacement member including a rail memberextending a second length between a proximal end and a distal end andbeing positioned within the rail receiving channel of the guide member,and a vertically extending member coupled to the distal end of the railmember, the vertically extending member including a plurality of needlereceiving ports, the guide member further including a pair ofstabilization members extending away from the rail receiving channel;positioning the vertically extending member of the displacement memberadjacent the perineal access site of the patient; inserting an accessneedle through one of the plurality of needle receiving ports and intothe perineal access site of the patient, the access needle positionedwithin the sagittal imaging plane; and inserting a needle through theaccess needle and into a first location of the prostate of the patient.12. The method of claim 11, further comprising: contacting a distal endof the pair of stabilization members of the guide member with theperineal access site of the patient, the pair of stabilization membersbeing spaced apart from each other and positioned on opposite sides ofthe rail receiving channel.
 13. The method of claim 11, furthercomprising injecting a substance into the patient via the needle. 14.The method of claim 11, further comprising taking a first biopsy of thefirst location of the prostate of the patient via the needle.
 15. Themethod of claim 14, further comprising taking a second biopsy of asecond location of the prostate of the patient via the needle, thesecond location being different than the first location.
 16. The methodof claim 15, wherein the access needle remains positioned within theperineal access site of the patient for the first biopsy and the secondbiopsy.
 17. The method of claim 11, wherein the rail receiving channelis positioned parallel with a longitudinal axis of the transrectalultrasound probe.
 18. The method of claim 11, wherein the displacementmember includes an end plate coupled to the proximal end of the railmember, the end plate configured to contact a proximal end of the guidemember in order to limit displacement of the displacement memberrelative to the guide member.
 19. The method of claim 11, wherein theplurality of needle receiving ports portion comprises at least fiveneedle receiving ports oriented vertically relative to the rail member.20. The method of claim 11, further comprising engaging a portion of theguide member to the perineal access site of the patient prior toinserting the access needle into the perineal access site of thepatient.